Location:
Category: Regulatory
Posted Date: January 14, 2025
Closing Date for Applications: January 28, 2025 (COB)
GSK is a global biopharmaceutical company with the mission to unite science, technology, and talent to get ahead of disease together. We focus on four core therapeutic areas:
At GSK, we aim to positively impact the health of 2.5 billion people over the next 10 years. We also offer a workplace where people feel valued, safe, and included, providing a competitive salary, benefits, and well-being programs to support personal and professional growth.
Hybrid Working Model:
Our Performance with Choice program allows flexibility, empowering you to balance remote and in-office work.
We are seeking an ambitious Regulatory Project Manager to join GSK’s Classic & Established Products (CEP) portfolio. This individual will be responsible for ensuring the development and execution of regulatory strategies, managing the lifecycle of products, and ensuring compliance with both GSK’s internal processes and regulatory requirements. The Regulatory Project Manager will act as the Global Regulatory Lead for assigned assets and engage with multiple internal and external stakeholders.
Global Regulatory Leadership:
Lead the regulatory strategy for assigned CEP assets and ensure the maintenance of marketing authorizations (MAs), including discontinuations.
Agency Communication:
Serve as the main point of contact for regulatory agencies, including the European Medicines Agency (EMA) and other European Local Health Authorities for National, Centralized, and Mutual Recognition procedures.
Cross-Functional Collaboration:
Work with teams from commercial, supply chain, medical, clinical, and regulatory labelling to ensure the regulatory strategy supports global and regional needs.
Lifecycle Management:
Oversee the lifecycle of marketed products, ensuring compliance with global/regional regulatory requirements (e.g., renewals, label updates, and safety reports).
Proactive Problem Solving:
Identify potential issues early, proactively resolve them, and escalate as necessary.
Stakeholder Engagement:
Build and maintain productive relationships with internal teams and regulatory agencies to ensure the smooth execution of regulatory activities.
At GSK, we offer:
We foster an environment where people can grow, innovate, and contribute to making a difference in the world.
GSK is committed to providing equal opportunities to all candidates. We are an affirmative action employer and provide equal consideration for all applicants regardless of race, gender, religion, sexual orientation, disability, or any other protected class.
To apply, please submit a cover letter and CV outlining how your skills and experiences align with the job requirements. This information will be used to assess your suitability for the role.
January 28, 2025 (COB)
GSK does not accept unsolicited referrals from recruitment agencies. All agencies must obtain prior written consent from GSK’s HR or Procurement Department before submitting any candidates.
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
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