GSK Biological Sciences Regulatory Specialist Vacancy Available
GSK Biological Sciences Regulatory Specialist Vacancy Available. GlaxoSmithKline Regulatory Specialist, CMC Variations job opportunities. CMG Regulatory Specialist, CMC Variations Careers at GSK. GlaxoSmithKline GSK Bengaluru vacancies for Regulatory Specialist. Check out all of the details below:
Name of the Position: Regulatory Specialist, CMC Variations
Locations: Bangalore, India
Req ID: 268262
This role will provide YOU with the opportunity to lead key activities to progress YOUR career. These responsibilities consist of several of the following.
- With minimal input from the manager, executes agreed dossier strategy
- With minimal input from the manager, manages several 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 as well as info packages. Communicates with the line manager to identify issues that have business impact.
- May have dossier review responsibilities for peers and might identify improvement opportunities for Regulatory processes, policies as well as systems.
- Developing an understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review as well as approval of global regulatory applications.
- Understands internal/external Regulatory environment
- Actively builds an organisational network.
- Communicates across GSK, with minimal input from manager concerning project and policy issues guaranteeing optimal position for GSK.
We are looking for an experienced individual as well as if you have these skills, we want to speak with you.
- Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment.
- Minimum 4-5 years of relevant experience
- Broad understanding of the pharmaceutical industry, drug development environment, as well as R&D processes and also 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
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