Pharma Jobs in Bangalore: GSK is Hiring for the position of Regulatory Associate Manager |
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Are you currently looking for Pharma Jobs in Bangalore? GSK is inviting applications for the position of Regulatory Associate Manager I in Bengaluru. This pivotal role offers the opportunity to support regulatory activities for new product registrations and lifecycle management while collaborating with global teams. Join GSK Career committed to uniting science, technology, and talent to help millions live healthier lives
Job Details:
- Job Title: Regulatory Associate Manager I
- Location: Bengaluru, India
- Department: Regulatory Affairs
- Job ID: 429729
About the Company:
GSK is a global biopharma leader committed to uniting science, technology, and talent to get ahead of disease together. With a purpose-driven approach, GSK focuses on discovering, developing, and delivering innovative vaccines and specialty medicines that prevent and treat diseases worldwide.
Headquartered in the United Kingdom, GSK operates in over 100 countries, positively impacting millions of lives through its focus on four key therapeutic areas — infectious diseases, HIV, oncology, and immunology. The company’s bold ambition is to improve the health of 2.5 billion people by the end of the decade, by accelerating R&D and leveraging cutting-edge scientific advancements.
GSK fosters a culture that is ambitious for patients, accountable for impact, and committed to doing the right thing. Through continuous innovation and a strong focus on inclusion and sustainability, GSK empowers its people to thrive while advancing global healthcare for a healthier future.
Education:
Master’s degree in Pharmacy/ Related fields.
Key Responsibilities:
- Independently and confidently executes agreed dossier strategy.
- Independently manages multiple Rx and/or Vx project assignments simultaneously; assignments will range in complexity, but more complex work is expected.
- Independently completes data assessment to ensure dossier is fit for purpose.
- Identifies risks associated with submission data and information packages.
- Escalates issues with line manager that have business impact.
- May act as reviewer/approver for dossiers prepared by peers and identifies improvement opportunities for Regulatory processes, policies and systems.
- Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications. May provide consultation and solutions being the subject matter expert in specific areas of expertise. Acts as mentor/trainer for new staff.
- Understands internal/external Regulatory environment.
- Actively builds an organisational network (PSC, LOC, PO and other relevant stakeholders), promotes and is engaged in knowledge and experience sharing.
- Communicates across GSK, as necessary regarding project and policy issues ensuring optimum position for GSK.
Preferred Skills:
- Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
- Global Regulatory submission experience – Knowledge of regulatory agency guidelines.
- Excellent organizational 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.
