Pharma Regulatory Specialist. GSK invites postgraduate and undergraduate Pharma candidates for the post of Specialist. Interested and Eligible candidates in the field of the pharma may apply for this post. Check out all the details on the same below:
Job Title: Regulatory Specialist, Variations – Senior
Minimum Experience:
- Minimum 4-5 years of relevant experience
- Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
- Global/ EMAP Regulatory submission experience – Knowledge of regulatory agency guidelines\
- Excellent organisational skills, attention to detail and commitment to deliver high-quality output, even under pressures sometimes demanded by regulatory deadlines
- Excellent written and verbal communication skills and ability to present information in a clear and concise manner
- Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience
- Ability to build effective working relationships and work in a matrix environment effectively
- Ability to think flexibly in order to meet constantly shifting priorities and timelines.
Key Responsibilities:
- With minimal input from the manager, executes agreed dossier strategy
- With minimal input from the manager, manages multiple project assignments (e.g.,
- Variations <CMC & Therapeutic>, Product Expansion dossiers, Renewals, MSRs <CMC&non-CMC>) simultaneously; dossiers will range in complexity
- With minimal input from the manager, completes data assessment to ensure dossier is fit for purpose.
- With minimal input from the manager, identifies risks associated with submission data and information packages.
- Communicates with the line manager to identify issues that have business impact.
- May have dossier review responsibilities for peers and may identify improvement opportunities for Regulatory processes, policies and systems.
- Developing an understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global regulatory applications.
- Understands internal/external regulatory environment.
- Actively builds an organisational network.
- Communicates across GSK, with minimal input from the manager regarding project and policy issues ensuring the optimum position for GSK.
Editor’s Note: GSK Regulatory Specialist Subscribe to Rasayanika for latest chemistry and Pharma job openings, follow us on Facebook and Whatsapp and subscribe to our youtube channel for latest updates on chemistry and Pharma jobs and much more.
