2 Remote Pharmaceutical Regulatory Affairs Specialist jobs in whatjobs
Pharmaceutical Regulatory Affairs Specialist
Posted 19 days ago
Job Viewed
Job Description
Our client, a prominent player in the pharmaceutical industry, is seeking a highly skilled and meticulous Pharmaceutical Regulatory Affairs Specialist. This is a fully remote position, offering the flexibility to work from anywhere while contributing to critical regulatory submissions and strategies. You will be responsible for ensuring compliance with all relevant national and international pharmaceutical regulations. This includes preparing, compiling, and submitting regulatory dossiers for new drug applications, variations, and post-approval changes. The ideal candidate will possess a deep understanding of regulatory requirements across various markets, exceptional attention to detail, and strong scientific writing skills. You will liaise with regulatory authorities, manage submission timelines, and stay abreast of evolving regulatory landscapes. This role requires a proactive approach to identifying potential regulatory challenges and developing effective solutions. Collaboration with R&D, manufacturing, and quality assurance teams will be integral to your success. We are seeking an individual with a strong scientific background and a proven ability to navigate complex regulatory frameworks. If you are passionate about ensuring patient access to safe and effective medicines through expert regulatory guidance, this is an exceptional opportunity. This fully remote role supports operations relevant to the Naivasha, Nakuru, KE region.
Key Responsibilities:
Key Responsibilities:
- Prepare, review, and submit regulatory dossiers for product registrations, variations, and renewals in accordance with global regulatory guidelines.
- Maintain a thorough understanding of current and emerging pharmaceutical regulations and guidelines in target markets.
- Liaise with national and international health authorities on regulatory submissions and inquiries.
- Assess the regulatory implications of product changes, manufacturing processes, and quality systems.
- Provide regulatory guidance and support to cross-functional teams, including R&D, clinical, manufacturing, and marketing.
- Ensure compliance with labeling requirements and review promotional materials for regulatory accuracy.
- Manage the lifecycle of regulatory approvals and maintain regulatory documentation.
- Conduct regulatory intelligence activities to identify new requirements and opportunities.
- Participate in regulatory audits and inspections as required.
- Develop and implement regulatory strategies to support product development and lifecycle management.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field. A higher degree or specialized certifications in Regulatory Affairs are highly desirable.
- Minimum of 5 years of experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting regulatory dossiers (e.g., CTD, eCTD).
- In-depth knowledge of global pharmaceutical regulatory requirements (e.g., FDA, EMA, ICH guidelines).
- Excellent scientific writing, analytical, and problem-solving skills.
- Strong attention to detail and accuracy.
- Effective communication and interpersonal skills, with the ability to collaborate with diverse teams.
- Proficiency in regulatory information management systems and standard office software.
- Ability to work independently and manage multiple projects in a remote setting.
This advertiser has chosen not to accept applicants from your region.
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Pharmaceutical Regulatory Affairs Specialist
Posted 19 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a highly motivated and experienced Pharmaceutical Regulatory Affairs Specialist to join their dynamic team. This role is essential for ensuring compliance with all national and international regulations governing pharmaceutical products. This is a fully remote position, allowing you to contribute your expertise from anywhere. You will be responsible for preparing and submitting regulatory filings, interacting with health authorities, and staying abreast of evolving regulatory landscapes. This position demands meticulous attention to detail, a deep understanding of pharmaceutical regulations, and excellent communication skills.
Responsibilities:
Responsibilities:
- Prepare, review, and submit regulatory documentation for new drug applications (NDAs), variations, and other regulatory submissions in accordance with relevant guidelines.
- Liaise with regulatory agencies (e.g., FDA, EMA, WHO) to facilitate the approval process and respond to queries.
- Monitor and interpret regulatory guidelines and advise project teams on their impact.
- Ensure that all company products comply with current regulatory requirements in target markets.
- Maintain regulatory databases and ensure the accuracy of product registration information.
- Collaborate with R&D, Quality Assurance, Manufacturing, and Marketing departments to gather necessary data for submissions.
- Develop and maintain regulatory strategies for product development and lifecycle management.
- Review and approve labeling, promotional materials, and advertising for regulatory compliance.
- Manage post-approval changes and ensure timely submissions of variations.
- Participate in regulatory inspections and audits.
- Stay informed about global regulatory trends and competitor activities.
- Provide training to internal staff on regulatory requirements and best practices.
- Assess the regulatory feasibility of new product concepts and development plans.
- Contribute to the continuous improvement of regulatory processes and systems.
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
- Minimum of 5 years of experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting various types of regulatory dossiers (e.g., CTD format).
- In-depth knowledge of global pharmaceutical regulatory requirements and guidelines.
- Familiarity with regulatory submission platforms and e-filing processes.
- Excellent understanding of drug development processes, manufacturing, and quality control.
- Strong analytical and problem-solving skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
- Meticulous attention to detail and commitment to accuracy.
- Ability to work independently and manage multiple projects simultaneously in a remote environment.
- Strong interpersonal skills for effective collaboration with cross-functional teams and health authorities.
- Proficiency in using regulatory information management systems (RIMS) is a plus.
- Experience with biologics or specialized therapeutic areas is advantageous.
This advertiser has chosen not to accept applicants from your region.
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