2 Senior Regulatory Affairs Specialist Pharmaceutical Remote jobs in whatjobs
Senior Regulatory Affairs Specialist - Pharmaceutical - Remote
Posted 10 days ago
Job Viewed
Job Description
Our client, a dynamic and growing pharmaceutical company, is seeking a highly proficient Senior Regulatory Affairs Specialist to join their team in a fully remote capacity. This critical role will involve managing all aspects of regulatory submissions and ensuring compliance with national and international pharmaceutical regulations. You will be responsible for preparing, reviewing, and submitting regulatory dossiers for drug product registrations, variations, and renewals. This includes ensuring adherence to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP). You will liaise with regulatory authorities, health ministries, and other relevant agencies to facilitate timely approvals and address queries. The ideal candidate will possess a strong understanding of the drug development lifecycle and extensive experience with regulatory submission processes in key markets. Expertise in navigating the regulatory landscape for pharmaceuticals, biologics, and medical devices is essential. You will stay updated on evolving regulatory requirements and provide strategic guidance to internal teams, including R&D, manufacturing, and marketing. This position demands exceptional attention to detail, strong analytical skills, and the ability to manage complex projects independently. Excellent written and verbal communication skills are vital for clear and effective interaction with both internal stakeholders and external regulatory bodies. As a fully remote role, you will need to be self-motivated and organized, capable of working autonomously while maintaining collaborative relationships with colleagues. This is an excellent opportunity to contribute to bringing vital medicines to patients worldwide from the convenience of your home. The role supports strategic initiatives within **Thika, Kiambu, KE**, but is a remote position.
This advertiser has chosen not to accept applicants from your region.
0
Senior Regulatory Affairs Specialist - Pharmaceutical Remote
Posted 4 days ago
Job Viewed
Job Description
Our client is a dynamic pharmaceutical company seeking a highly experienced Senior Regulatory Affairs Specialist to manage regulatory submissions and compliance strategies. This is a fully remote position, offering a unique opportunity for a regulatory expert to contribute to global drug development and commercialization efforts from anywhere. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and ensuring adherence to global regulatory guidelines. This role requires a deep understanding of pharmaceutical regulations, excellent scientific writing skills, and a proven track record in navigating complex regulatory landscapes. The ideal candidate will possess strong analytical and strategic thinking abilities, exceptional communication skills, and the capacity to work independently and manage multiple projects concurrently in a remote environment.
Key responsibilities include:
Key responsibilities include:
- Preparing, reviewing, and submitting regulatory dossiers for new drug applications (NDAs), variations, and other regulatory filings across various global markets.
- Interpreting and applying global regulatory guidelines and requirements relevant to pharmaceutical products.
- Serving as the primary point of contact with health authorities (e.g., FDA, EMA, national agencies).
- Developing and executing regulatory strategies to support product development and lifecycle management.
- Assessing the regulatory impact of proposed product changes and manufacturing processes.
- Ensuring compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant regulations.
- Reviewing and approving labeling, promotional materials, and advertising to ensure regulatory compliance.
- Managing post-approval regulatory activities, including annual reports and renewals.
- Providing regulatory guidance and support to internal teams, including R&D, clinical, manufacturing, and marketing.
- Tracking regulatory intelligence and communicating emerging trends and requirements to stakeholders.
- Participating in regulatory audits and inspections.
- Developing and maintaining strong relationships with regulatory agencies.
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Senior regulatory affairs specialist pharmaceutical remote Jobs in Kenya !
1