526 Pharmaceuticals jobs in Kenya
Clinical Research Associate - Pharmaceuticals
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Senior Formulation Scientist - Pharmaceuticals
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Key responsibilities include:
- Designing and developing robust pharmaceutical formulations for small molecules and biologics.
- Conducting pre-formulation studies, including physicochemical characterization and compatibility assessments.
- Investigating and optimizing formulation excipients and manufacturing processes.
- Developing and validating analytical methods for formulation characterization and quality control.
- Leading stability studies to assess the shelf-life and degradation pathways of drug products.
- Troubleshooting formulation-related issues and implementing corrective actions.
- Collaborating with process development, analytical development, and regulatory affairs teams.
- Preparing technical documentation, including formulation development reports, protocols, and batch records.
- Staying current with industry trends, scientific literature, and new technologies in pharmaceutical formulation and drug delivery.
- Mentoring junior scientists and contributing to the scientific advancement of the R&D department.
Qualifications:
- Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemistry, or a related field.
- Minimum of 6 years of hands-on experience in pharmaceutical formulation development.
- Proven expertise in various dosage forms, including solid oral dosage forms, parenteral, and topical formulations.
- Strong knowledge of drug delivery systems, excipient science, and biopharmaceutics.
- Experience with analytical techniques such as HPLC, GC, DSC, TGA, XRPD, and dissolution testing.
- Familiarity with GMP regulations and guidelines relevant to formulation development and manufacturing.
- Excellent problem-solving skills and a strong ability to interpret scientific data.
- Exceptional written and verbal communication skills.
- Ability to work independently and effectively manage projects in a fully remote team environment.
- A passion for scientific innovation and a commitment to quality.
Clinical Research Associate - Pharmaceuticals
Posted 5 days ago
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- Monitoring assigned clinical trial sites to ensure compliance with Good Clinical Practice (GCP) guidelines, protocols, and regulatory requirements.
- Conducting site initiation visits, routine monitoring visits, and close-out visits.
- Verifying the accuracy, completeness, and validity of clinical data through source data verification.
- Identifying, documenting, and resolving site-level issues and deviations.
- Ensuring timely submission of all required study documents.
- Training and mentoring site staff on study-specific procedures and regulatory requirements.
- Building and maintaining strong working relationships with investigators and site personnel.
- Communicating effectively with internal project teams regarding site progress and challenges.
- Assisting in the preparation of study-related documents and reports.
Remote Quality Assurance Specialist, Pharmaceuticals
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Senior Regulatory Affairs Specialist - Pharmaceuticals
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Key Responsibilities:
- Develop and execute regulatory strategies for product development and lifecycle management, ensuring alignment with company objectives and global regulatory requirements.
- Prepare, review, and submit regulatory dossiers (e.g., IND, NDA, MAA, ANDA) to health authorities such as the FDA, EMA, and other global agencies.
- Interpret and apply evolving regulatory guidelines, standards, and legislation to ensure ongoing compliance.
- Liaise directly with regulatory agencies to facilitate communication, respond to inquiries, and resolve issues during the review process.
- Provide regulatory guidance and support to internal teams, including R&D, clinical affairs, manufacturing, quality assurance, and marketing.
- Conduct regulatory due diligence for potential business development opportunities and product acquisitions.
- Maintain regulatory documentation, databases, and filing systems, ensuring accuracy and completeness.
- Monitor the regulatory environment for changes that may impact the company's products and provide proactive recommendations.
- Lead regulatory meetings and contribute to strategic planning sessions.
- Stay current with scientific and technical developments relevant to pharmaceutical regulatory affairs.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, Life Sciences, or a related field.
- Minimum of 6 years of experience in pharmaceutical regulatory affairs, with a strong focus on submissions and agency interactions.
- In-depth knowledge of global regulatory requirements and guidelines (e.g., ICH, FDA, EMA, PMDA).
- Proven experience in preparing and successfully submitting various types of regulatory dossiers.
- Excellent written and verbal communication skills, including strong technical writing abilities.
- Detail-oriented with strong analytical and problem-solving skills.
- Ability to manage multiple projects simultaneously in a fast-paced, remote environment.
- Proficiency in regulatory information management (RIM) systems is desirable.
- Strong understanding of drug development processes and pharmaceutical manufacturing.
- Ability to work independently and collaboratively within a remote team structure.
Senior Regulatory Affairs Specialist - Pharmaceuticals
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Key responsibilities include:
- Preparing and submitting regulatory dossiers (e.g., CTD, ANDA, NDA) for new drug applications and variations in various markets.
- Reviewing and approving labeling, promotional materials, and advertising to ensure regulatory compliance.
- Managing post-approval regulatory activities, including amendments, supplements, and annual reports.
- Interacting with regulatory health authorities (e.g., KEBS, FDA, EMA) for submissions and inquiries.
- Providing regulatory guidance and strategy to cross-functional teams, including R&D, clinical, manufacturing, and quality assurance.
- Staying updated on current and emerging regulatory trends, guidelines, and legislation affecting the pharmaceutical industry.
- Conducting regulatory intelligence assessments and contributing to the development of regulatory strategies.
- Maintaining regulatory compliance databases and ensuring accurate record-keeping.
- Leading and participating in regulatory inspections and audits.
- Assisting in the development and implementation of regulatory affairs policies and procedures.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field; advanced degree (M.S., Ph.D., Pharm.D.) is a plus.
- Minimum of 5 years of experience in pharmaceutical regulatory affairs.
- Proven experience with regulatory submissions and interactions with health authorities.
- Strong knowledge of GMP, GCP, and GLP principles.
- Familiarity with global regulatory requirements and submission formats (e.g., ICH guidelines, CTD).
- Excellent written and verbal communication skills, with meticulous attention to detail.
- Strong analytical and problem-solving abilities.
- Ability to work independently and collaboratively in a fully remote, international team environment.
- Proficiency in Microsoft Office Suite.
Senior Remote Project Manager (Pharmaceuticals)
Posted today
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Key Responsibilities:
- Develop detailed project plans, including scope, timelines, resources, and budgets, for pharmaceutical projects.
- Manage day-to-day operational aspects of projects, ensuring clear communication and alignment across remote teams.
- Identify, assess, and mitigate project risks and issues, implementing proactive solutions.
- Facilitate project meetings, including kick-offs, status updates, and retrospectives, utilizing virtual collaboration tools effectively.
- Track project progress, monitor key performance indicators (KPIs), and provide regular status reports to stakeholders and senior management.
- Manage vendor relationships and contract negotiations as required for project delivery.
- Ensure adherence to all regulatory requirements and quality standards relevant to the pharmaceutical industry.
- Foster a collaborative and productive team environment, motivating team members to achieve project goals.
- Drive continuous improvement in project management methodologies and processes.
- Effectively manage project changes and scope creep, ensuring alignment with overall project objectives.
- Prepare and present project documentation, including proposals, plans, and closure reports.
- Coordinate with cross-functional teams such as R&D, Clinical Operations, Regulatory Affairs, and Manufacturing.
Qualifications:
- Bachelor's degree in a relevant field (e.g., Science, Business Administration); PMP or equivalent certification is highly desirable.
- Minimum of 8 years of progressive experience in project management, with at least 5 years specifically within the pharmaceutical or biotechnology industry.
- Proven ability to manage multiple complex projects simultaneously.
- Demonstrated success in delivering projects on time and within budget constraints.
- Expertise in project management software and tools (e.g., MS Project, Asana, Jira).
- Strong understanding of pharmaceutical development phases (e.g., pre-clinical, clinical trials, regulatory submission).
- Excellent leadership, communication, negotiation, and interpersonal skills, with the ability to influence stakeholders at all levels.
- Exceptional organizational and time management skills, with a keen eye for detail.
- Ability to thrive in a fast-paced, dynamic, and remote work environment.
- Proficiency in risk management and change control processes.
- Experience with Agile or Waterfall project management methodologies.
This remote role offers an excellent opportunity to lead impactful projects and shape the future of pharmaceutical innovation.
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Lead Clinical Research Associate (Pharmaceuticals)
Posted 2 days ago
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Responsibilities:
- Lead, mentor, and manage a team of Clinical Research Associates, providing guidance and support.
- Oversee the conduct of clinical trials at investigative sites to ensure compliance with GCP, ICH guidelines, and study protocols.
- Develop and implement site monitoring strategies and plans.
- Conduct site initiation visits, interim monitoring visits, and site termination visits (virtually or through designated on-site personnel).
- Ensure accurate and timely data collection, verification, and query resolution.
- Manage relationships with investigator sites, principal investigators, and site staff.
- Identify and resolve site-level issues and deviations promptly.
- Review and ensure the quality of essential study documents.
- Contribute to the development of study protocols, case report forms (CRFs), and other study documents.
- Prepare site monitoring reports and track action items for site and CRA follow-up.
- Oversee site budget adherence and resource allocation.
- Ensure timely reporting of adverse events and serious adverse events according to regulatory requirements.
- Collaborate with internal teams, including data management, biostatistics, and regulatory affairs.
- Train site staff on study-specific procedures and GCP compliance.
- Contribute to the selection and qualification of new investigator sites.
- Drive efficiency and continuous improvement in clinical trial monitoring processes.
- Manage the archiving of essential study documents.
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related scientific discipline.
- Minimum of 5 years of progressive experience as a Clinical Research Associate, with at least 2 years in a lead or supervisory role.
- Extensive knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.
- Proven experience in monitoring multiple clinical trials across various therapeutic areas.
- Strong leadership, team management, and motivational skills.
- Excellent understanding of clinical trial processes, from site selection to close-out.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Exceptional communication, interpersonal, and problem-solving skills.
- Ability to manage multiple priorities and meet deadlines in a fast-paced, remote environment.
- Strong analytical skills and attention to detail.
- Experience in pharmaceutical or biotechnology industries is essential.
- Must have a reliable internet connection and a dedicated workspace.
Remote Senior Research Scientist - Pharmaceuticals
Posted 2 days ago
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Responsibilities:
- Design and conduct in-vitro and ex-vivo experiments to assess drug efficacy and safety.
- Analyze complex biological data sets using statistical and bioinformatics tools.
- Develop and validate novel assays for drug screening and target validation.
- Interpret experimental results and formulate research hypotheses.
- Collaborate with internal teams and external partners on research projects.
- Prepare and present research findings at scientific meetings and in publications.
- Contribute to the writing of grant proposals and regulatory documents.
- Mentor junior scientists and research associates.
- Stay abreast of the latest advancements in pharmaceutical research and technology.
- Manage research timelines and resources effectively in a remote setting.
- Ph.D. in Molecular Biology, Pharmacology, Biochemistry, or a closely related field.
- Minimum of 7 years of post-doctoral research experience in the pharmaceutical industry or academia.
- Extensive experience in experimental design, execution, and data analysis.
- Proven expertise in relevant therapeutic areas and disease mechanisms.
- Strong understanding of drug discovery and development processes.
- Excellent written and verbal communication skills.
- Demonstrated ability to work independently and collaboratively in a virtual environment.
- Proficiency in relevant scientific software and databases.
- Experience with biological modeling or cheminformatics is a plus.
- A strong publication record in peer-reviewed journals.
Pharmaceutical Sales Representative
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