What Regulatory Affairs Specialist Jobs are in Remote?
Showing 122 Regulatory Affairs Specialist jobs in Remote
Senior Regulatory Affairs Specialist - Cosmetics (Remote)
Posted 5 days ago
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Job Description
- Oversee and manage global regulatory compliance for all cosmetic and personal care products.
- Prepare, review, and submit regulatory dossiers and product registrations in various international markets.
- Interpret and communicate complex regulatory requirements to internal teams, including R&D, marketing, and operations.
- Monitor changes in global regulations and assess their impact on the company's products and business operations.
- Conduct regulatory due diligence for new product development, supplier qualification, and market expansions.
- Develop and maintain regulatory databases, product compliance documentation, and safety data sheets (SDS).
- Liaise with regulatory authorities, industry associations, and external consultants as needed.
- Provide regulatory support for product labeling, advertising claims, and marketing materials.
- Assist in the resolution of regulatory compliance issues and inspections.
- Stay updated on industry best practices and emerging regulatory trends in the beauty and wellness sector.
- Bachelor's degree in Chemistry, Pharmacy, Law, or a related scientific or legal field. A Master's degree is preferred.
- Minimum of 5-7 years of experience in regulatory affairs, specifically within the cosmetics, personal care, or pharmaceutical industry.
- In-depth knowledge of global cosmetic regulations (e.g., FDA, EU Cosmetic Regulation, Health Canada, ASEAN).
- Proven experience in preparing and submitting product registrations and regulatory dossiers.
- Strong analytical and problem-solving skills with exceptional attention to detail.
- Excellent written and verbal communication skills, including the ability to effectively negotiate and communicate with regulatory bodies.
- Proficiency in regulatory information management systems and databases.
- Ability to work independently, manage multiple priorities, and meet strict deadlines in a remote setting.
- Must be legally eligible to work remotely from **Eldoret, KE**, with a reliable internet connection and a suitable home office environment.
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Remote Senior Pharmaceutical Regulatory Affairs Specialist
Posted 5 days ago
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Job Description
Key Responsibilities
- Develop and implement global regulatory strategies for product development, registration, and lifecycle management.
- Prepare, review, and submit high-quality regulatory dossiers (e.g., CTD, ANDA, NDA) to health authorities worldwide (e.g., FDA, EMA, MHRA).
- Act as the primary point of contact for regulatory agencies, responding to queries and managing submissions.
- Interpret and communicate complex regulatory requirements to internal stakeholders, including R&D, clinical, manufacturing, and marketing teams.
- Conduct regulatory due diligence for potential business development activities and product acquisitions.
- Ensure ongoing compliance with post-approval commitments, variations, and annual reports.
- Monitor and analyze regulatory changes and guidance documents, assessing their impact on the company's product portfolio.
- Provide strategic regulatory input for product labeling, advertising, and promotional materials.
- Lead and participate in regulatory meetings with health authorities.
- Contribute to the development and implementation of departmental SOPs and quality systems.
- Bachelor's degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology) or equivalent experience. Advanced degree (Master's or Pharm.D.) is highly desirable.
- Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs, with a strong focus on global submissions.
- In-depth knowledge of regulatory requirements and guidelines in major markets (US, EU, Japan, etc.).
- Proven track record of successful regulatory submissions and approvals.
- Experience with eCTD submission software and regulatory information management systems (RIMS).
- Strong understanding of drug development processes, GxP, and pharmaceutical manufacturing.
- Excellent written and verbal communication skills, with the ability to negotiate effectively with regulatory authorities.
- Exceptional analytical, strategic thinking, and problem-solving capabilities.
- Ability to manage multiple projects simultaneously and work independently in a remote setting.
- Proactive approach to identifying and addressing regulatory challenges.
- Highly competitive salary package commensurate with experience.
- Comprehensive remote work setup allowance.
- Full health, dental, and vision insurance coverage.
- Generous paid time off and flexible working hours.
- Professional development opportunities, including training and conference attendance.
- Retirement savings plan with company contributions.
- Opportunity to work with a global leader in the pharmaceutical industry from home.
- Direct impact on bringing essential medicines to patients worldwide.
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Principal Regulatory Affairs Specialist - Remote
Posted 10 days ago
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Job Description
- Develop and implement global regulatory strategies for new product development and lifecycle management.
- Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs) to health authorities worldwide.
- Interpret and advise on complex regulatory requirements and guidelines applicable to pharmaceutical products.
- Serve as the primary regulatory contact with health authorities for assigned projects.
- Conduct regulatory intelligence activities to stay informed of evolving regulations and competitor activities.
- Collaborate with internal teams (R&D, Clinical, Manufacturing, Marketing) to ensure regulatory compliance throughout product development and commercialization.
- Manage post-approval regulatory activities, including variations, supplements, and annual reports.
- Provide regulatory input into product labeling, promotional materials, and advertising.
- Lead regulatory aspects of due diligence activities for potential acquisitions or partnerships.
- Mentor and guide junior regulatory affairs professionals.
- Master's degree or Ph.D. in a scientific discipline (e.g., Pharmacy, Chemistry, Biology) or a related field.
- A minimum of 10 years of progressive experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Extensive experience in preparing and submitting various regulatory dossiers to major health authorities (e.g., FDA, EMA).
- Deep understanding of pharmaceutical regulations, guidelines (ICH, GMP), and submission requirements.
- Proven ability to develop and execute successful global regulatory strategies.
- Excellent written and verbal communication skills, with strong attention to detail.
- Demonstrated experience in leading regulatory projects and cross-functional teams.
- Proficiency in regulatory information management systems and standard office software.
- Ability to work independently and effectively in a remote team environment.
- Experience with biologics or complex generics is a plus.
- Highly attractive compensation package, including base salary and potential bonuses.
- Fully remote position, offering unparalleled flexibility and autonomy.
- Comprehensive health insurance benefits.
- Generous paid time off and holiday schedule.
- Professional development support, including attendance at key industry conferences.
- Opportunities for significant career growth and leadership.
- Access to a global network of pharmaceutical experts.
- Home office stipend and technology support.
- Be part of a mission-driven organization focused on improving global health.
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Remote Legal Counsel, Corporate and Securities
Posted 3 days ago
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Job Description
- Advise on corporate governance matters, including board of directors' activities, committee support, and shareholder relations.
- Ensure compliance with SEC reporting requirements (e.g., 10-K, 10-Q, 8-K, proxy statements).
- Support public and private securities offerings, including debt and equity financings.
- Assist with stock exchange compliance and listing requirements.
- Manage subsidiary corporate governance and foreign entity compliance.
- Draft and review corporate and securities-related agreements and filings.
- Advise on executive compensation and employee equity plans.
- Support mergers, acquisitions, and other corporate transactions from a securities law perspective.
- Stay current with developments in corporate and securities law and provide relevant updates.
- Collaborate with internal teams and external counsel on various legal matters.
- Juris Doctor (JD) or equivalent law degree from a reputable institution.
- Admission to practice law in at least one U.S. state (or a comparable jurisdiction for international candidates).
- A minimum of 6 years of relevant experience in corporate and securities law, either in-house or at a law firm.
- In-depth knowledge of the Securities Act of 1933, the Securities Exchange Act of 1934, and SEC rules and regulations.
- Experience with public company reporting and corporate governance best practices.
- Proven ability to manage complex transactions and projects independently.
- Excellent written and verbal communication skills, with the ability to convey complex legal concepts clearly.
- Strong analytical and problem-solving skills.
- Ability to thrive in a fast-paced, remote work environment and collaborate effectively with distributed teams.
- High ethical standards and commitment to professional responsibility.
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Remote Legal Counsel, Technology Transactions
Posted 3 days ago
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Job Description
- Draft, review, negotiate, and manage technology and commercial agreements, including software licenses, SaaS agreements, cloud service agreements, and professional services agreements.
- Advise business teams on legal issues related to technology products, services, and intellectual property.
- Support the sales and procurement teams in negotiating favorable contract terms.
- Ensure compliance with data privacy regulations (e.g., GDPR, CCPA) in technology contracts.
- Manage contract lifecycles and maintain organized contract records.
- Conduct legal research and analysis on technology law issues.
- Collaborate with other legal department members on various projects.
- Identify and mitigate legal risks associated with technology transactions.
- Stay current with legal developments affecting the technology industry.
- Assist in the development of standard contract templates and playbooks.
- Juris Doctor (JD) or equivalent law degree from a reputable institution.
- Admission to practice law in at least one relevant jurisdiction.
- A minimum of 5 years of legal experience, with a significant focus on technology transactions and commercial contracts.
- In-depth knowledge of software licensing, SaaS, cloud computing, and related technology agreements.
- Familiarity with intellectual property law and data privacy regulations.
- Excellent drafting, negotiation, and communication skills.
- Ability to work independently, manage multiple priorities, and thrive in a fast-paced, remote environment.
- Strong analytical and problem-solving abilities.
- Experience working collaboratively with cross-functional teams.
- A business-oriented approach to problem-solving.
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Remote Legal Counsel, Mergers & Acquisitions
Posted 3 days ago
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Job Description
- Manage all legal aspects of the M&A process, from deal sourcing and due diligence to closing and post-merger integration.
- Structure, draft, negotiate, and advise on definitive agreements (e.g., stock purchase agreements, asset purchase agreements, merger agreements).
- Lead and coordinate legal due diligence investigations, identifying key risks and liabilities.
- Advise on deal structuring, financing arrangements, and regulatory approvals required for transactions.
- Work closely with business development and finance teams to assess strategic fit and financial viability of targets.
- Manage external legal counsel and other advisors involved in M&A transactions.
- Ensure compliance with securities laws, antitrust regulations, and other relevant legal requirements.
- Assist with post-merger integration planning and execution from a legal perspective.
- Develop and maintain internal playbooks and standard documentation for M&A activities.
- Stay abreast of market trends, legal developments, and best practices in M&A.
- Juris Doctor (JD) or equivalent law degree from a reputable institution.
- Admission to practice law in at least one relevant jurisdiction.
- A minimum of 10 years of substantial M&A experience, with a significant portion in-house at a large corporation or at a top-tier law firm.
- Proven track record of successfully managing and closing complex, cross-border M&A transactions.
- In-depth knowledge of M&A legal frameworks, corporate finance, and securities laws.
- Excellent negotiation, drafting, analytical, and strategic thinking skills.
- Exceptional project management abilities and experience managing multiple deals simultaneously.
- Strong interpersonal and communication skills, with the ability to effectively advise senior management and collaborate with diverse teams remotely.
- Ability to work independently, demonstrate strong judgment, and thrive in a fast-paced, remote environment.
- Experience in due diligence and post-merger integration is essential.
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Senior Aviation Regulatory Affairs Specialist (Remote)
Posted 10 days ago
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Job Description
- Monitor, research, and analyze aviation regulations and standards issued by international bodies (e.g., ICAO) and national authorities (e.g., FAA, EASA, KCAA).
- Interpret regulatory requirements and assess their impact on the company's products, services, and operations.
- Develop and implement compliance strategies and action plans to ensure adherence to all applicable regulations.
- Prepare and submit regulatory documentation, applications, and reports to relevant authorities.
- Act as the primary point of contact for regulatory agencies on compliance matters.
- Liaise with internal engineering, legal, quality, and business teams to provide regulatory guidance and support.
- Contribute to the development of company policies and procedures to align with regulatory changes.
- Manage certification and approval processes for new products and services.
- Represent the company in industry forums and working groups related to regulatory affairs.
- Maintain up-to-date knowledge of global aviation regulatory trends and best practices.
- Bachelor's degree in Aviation Law, Aviation Management, Engineering, or a related field. A Master's degree or legal qualification is a plus.
- Minimum of 7 years of experience in aviation regulatory affairs, compliance, or a related legal/policy role within the aerospace industry.
- In-depth knowledge of international aviation regulations (ICAO) and major national authorities (FAA, EASA).
- Proven experience in regulatory compliance, certification processes, and submission management.
- Strong analytical, research, and problem-solving skills.
- Excellent written and verbal communication skills, including the ability to negotiate and influence.
- Proficiency in legal and regulatory research databases and documentation tools.
- Ability to work independently, manage multiple projects simultaneously, and meet tight deadlines in a remote environment.
- High ethical standards and attention to detail.
- Fluency in English is required; proficiency in other languages is advantageous.
- Competitive salary and benefits package.
- Full remote work arrangement, providing significant flexibility.
- Comprehensive health, dental, and life insurance.
- Opportunities for professional growth, training, and international exposure.
- Work with a respected leader in the global aviation sector.
- Generous paid time off and flexible working hours.
- Supportive remote work environment with access to advanced collaboration tools.
- Contribution to shaping the future of aviation regulation and compliance.
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Job Description
- Develop, implement, and manage comprehensive global data privacy policies and procedures in compliance with GDPR, CCPA, and other applicable regulations.
- Provide expert legal advice to business units on data privacy implications of new products, services, and marketing initiatives.
- Conduct Data Protection Impact Assessments (DPIAs) and Privacy Impact Assessments (PIAs) for high-risk processing activities.
- Manage and respond to data subject access requests (DSARs) and other privacy rights requests.
- Oversee the investigation and remediation of data breaches and privacy incidents, coordinating with relevant internal teams and external authorities.
- Advise on cross-border data transfers and the legal mechanisms required for compliance.
- Conduct regular privacy training for employees across different departments and levels.
- Stay current with evolving data privacy laws, regulations, and enforcement trends globally, and proactively update policies and practices.
- Collaborate with engineering, product, and security teams to embed privacy-by-design principles into systems and processes.
- Engage with data protection authorities and other regulators as required.
- Juris Doctor (JD) or equivalent law degree from a reputable institution.
- Admission to practice law in at least one relevant jurisdiction (e.g., Kenya, or a major common law jurisdiction).
- A minimum of 8 years of legal experience, with a significant focus on data privacy, data protection, and cybersecurity law.
- In-depth knowledge of global privacy regulations (GDPR, CCPA, LGPD, etc.) and their practical application.
- Experience in advising multinational corporations on complex privacy matters.
- Certifications such as CIPP/E, CIPP/US, or CIPM are highly desirable.
- Exceptional analytical, problem-solving, and communication skills, with the ability to explain complex legal concepts clearly to non-legal audiences.
- Proven ability to work independently and manage a demanding workload in a remote setting.
- Demonstrated experience in building and maintaining strong relationships with diverse stakeholders.
- A proactive approach to identifying and mitigating legal and regulatory risks.
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Regulatory Affairs Specialist (Remote)
Posted 16 days ago
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Job Description
- Prepare, review, and compile high-quality regulatory submission documentation (e.g., INDs, NDAs, MAAs, supplements) in accordance with relevant agency guidelines (FDA, EMA, etc.).
- Manage and maintain regulatory filings throughout the product lifecycle, including annual reports, amendments, and variations.
- Interface with regulatory agencies on behalf of the company, responding to queries and facilitating communication.
- Ensure compliance with all applicable local, regional, and international regulations and guidelines related to pharmaceutical product development and marketing.
- Collaborate with cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Marketing, to provide regulatory guidance and ensure project timelines are met.
- Monitor regulatory intelligence and update internal stakeholders on changes in the regulatory landscape that may impact the company's products or strategy.
- Support regulatory strategy development for new product registrations and lifecycle management activities.
- Review promotional and advertising materials for regulatory compliance.
- Maintain regulatory databases and filing systems.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field. Advanced degree (e.g., Master's, Pharm.D.) is a plus.
- Minimum of 4 years of experience in regulatory affairs within the **pharmaceutical** or biotechnology industry.
- In-depth knowledge of regulatory requirements and guidelines in major markets (e.g., US, EU).
- Proven experience in preparing and submitting various types of regulatory dossiers.
- Strong understanding of drug development processes and pharmaceutical manufacturing.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with a talent for clear and concise documentation.
- Ability to manage multiple projects simultaneously and meet strict deadlines in a remote setting.
- Proficiency in using regulatory information management systems (RIMS) and common office software.
- Self-motivated with the ability to work independently and collaboratively in a virtual team environment.
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Job Description
- Provide expert legal advice on all aspects of employment law, including hiring, termination, employee discipline, and performance management.
- Draft, review, and update employment contracts, policies, and employee handbooks.
- Advise on compliance with Kenyan labor laws, regulations, and collective bargaining agreements.
- Manage and resolve employee grievances and disputes, including internal investigations.
- Represent the company in employment-related litigation, arbitration, and mediation proceedings.
- Advise on workplace safety and health regulations.
- Conduct training sessions for HR personnel and management on employment law issues.
- Stay current with changes in employment legislation and advise on their implications.
- Advise on workforce restructuring, redundancies, and business transfers.
- Ensure compliance with data privacy regulations as they apply to employee data.
- A Bachelor of Laws (LLB) degree from a recognized university.
- A Post Graduate Diploma in Legal Studies from the Kenya School of Law.
- Admitted to the Kenyan Bar as an Advocate of the High Court of Kenya.
- A minimum of 6 years of dedicated experience in employment law.
- In-depth knowledge of Kenyan employment legislation and case law.
- Proven experience in advising on complex employment issues and handling employment litigation.
- Excellent drafting, negotiation, and analytical skills.
- Strong interpersonal and communication skills, with the ability to build rapport and trust remotely.
- Ability to work independently, manage priorities, and deliver results in a remote setting.
- Experience in advising multinational corporations or fast-growing businesses is a plus.
- Competitive salary and potential for performance bonuses.
- Comprehensive health and wellness benefits.
- Opportunities for continuous professional development and training.
- Flexible remote working arrangement.
- A supportive and collaborative work culture focused on employee well-being.
- Chance to significantly impact HR policies and employee relations.
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