GlaxoSmithKline Recruitment 2020.GlaxoSmithKline Notification full detailes below.GlaxoSmithKline PLC is a global healthcare company.The Company focuses on its research across six areas: Respiratory diseases, human immunodeficiency virus (HIV)/infectious diseases, Vaccines, Immuno-inflammation, Oncology and Rare diseases.
Important Vacancy details:
- Post Name: Regulatory Specialist, Variations – Senior
- Experienced:5 to 7 years
- Location: Worli Mumbai, India; Bangalore, India
- Salary: NA
- Openings: NA
Note:If interested candidates can share your resume to mentioned mail ID Below.
Job Description: Hiring For Regulatory Specialist, Variations – Senior in GlaxoSmithKline! If interested candidates can share your resume to mentioned mail ID email@example.com
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following…
- With minimal input from manager, executes agreed dossier strategy
- With minimal input from 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 manager, completes data assessment to ensure dossier is fit for purpose.
- With minimal input from manager, identifies risks associated with submission data and information packages.
- Communicates with 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 manager regarding project and policy issues ensuring optimum position for GSK.
We are looking for professionals with these required skills to achieve our goals:
- Minimum 5-7 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.
Selection Process: The selection will be on the basis of Interview.
How to Apply : Click here for full details and Apply Online