2 Lead Pharmaceutical Regulatory Affairs Specialist Remote jobs in whatjobs
Lead Pharmaceutical Regulatory Affairs Specialist (Remote)
Posted 20 days ago
Job Viewed
Job Description
Our client, a leading name in the pharmaceutical industry, is actively seeking a highly experienced and detail-oriented Lead Pharmaceutical Regulatory Affairs Specialist. This is a fully remote role, allowing you to contribute from any location in Kenya. You will be instrumental in ensuring our pharmaceutical products comply with all national and international regulatory requirements throughout their lifecycle. This position demands a deep understanding of drug development, submission processes, and post-approval maintenance.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Develop and implement regulatory strategies for new and existing pharmaceutical products.
- Prepare, review, and submit regulatory dossiers (e.g., CTD, NDA, ANDA) to relevant health authorities.
- Monitor and interpret changes in pharmaceutical regulations and guidelines, providing proactive guidance to the organization.
- Liaise effectively with regulatory agencies, health authorities, and other stakeholders.
- Oversee the regulatory aspects of product lifecycle management, including variations, renewals, and amendments.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP).
- Provide regulatory input and support for product development, clinical trials, and marketing authorization applications.
- Manage regulatory documentation and databases, ensuring accuracy and completeness.
- Lead and mentor junior regulatory affairs professionals, fostering a collaborative and expert team environment.
- Conduct regulatory intelligence activities to stay abreast of evolving global regulatory landscapes.
Qualifications:
- Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
- Minimum of 10 years of progressive experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global pharmaceutical regulatory requirements (e.g., FDA, EMA, KEBS).
- Proven experience in preparing and submitting marketing authorization applications.
- Demonstrated experience managing regulatory submissions for various therapeutic areas.
- Excellent understanding of drug development processes and regulatory pathways.
- Strong analytical, problem-solving, and project management skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex regulatory issues clearly.
- Experience working in a remote or hybrid team setting is highly desirable.
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Lead Pharmaceutical Regulatory Affairs Specialist (Remote)
Posted 5 days ago
Job Viewed
Job Description
Our client is seeking a highly skilled and experienced Lead Pharmaceutical Regulatory Affairs Specialist to join their dynamic, fully remote team. This role is crucial for navigating the complex regulatory landscape of pharmaceutical product development, approval, and lifecycle management. You will be responsible for developing and implementing regulatory strategies, preparing and submitting comprehensive regulatory dossiers, and ensuring compliance with national and international regulations (e.g., FDA, EMA, WHO). The ideal candidate will possess a strong understanding of pharmaceutical science, clinical trial processes, and regulatory submission requirements. Experience in managing regulatory submissions for various product types (e.g., generics, biologics, new molecular entities) is essential. You will serve as a key liaison between the company and regulatory authorities, responding to inquiries and addressing regulatory challenges. This position requires exceptional analytical, communication, and project management skills, with the ability to lead a team and mentor junior specialists. As a remote-first role, you will need to be highly self-motivated, detail-oriented, and capable of managing multiple complex projects concurrently in a virtual environment. Your expertise will be vital in ensuring that our client's products reach patients safely and effectively. While the position is fully remote, it is integral to our client's operations and regulatory compliance efforts concerning products that impact the **Bungoma, Bungoma, KE** region and beyond. You will be a strategic partner in accelerating product development timelines and maintaining market access. If you are a seasoned regulatory affairs professional with a proven track record in the pharmaceutical industry and excel in a remote, collaborative setting, we invite you to apply.
This advertiser has chosen not to accept applicants from your region.
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