Instagram
youtube
Facebook

Regulatory Project Manager - Classic & Established Products

4+ years
Not Disclosed
10 Jan. 21, 2025
Job Description
Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Project Manager - Classic & Established Products

Location:

  • London, United Kingdom
  • Baar, Switzerland
  • Wavre, Belgium
  • Poznan Grunwaldzka, Poland

Category: Regulatory
Posted Date: January 14, 2025
Closing Date for Applications: January 28, 2025 (COB)


Company Overview:

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:

  • Infectious Diseases
  • HIV
  • Respiratory/Immunology
  • Oncology

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.


Job Overview:

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.


Key Responsibilities:

  • 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.


Qualifications & Skills:

Basic Qualifications:

  • Education: BSc in Biological or Healthcare Science, or equivalent.
  • Regulatory Experience: Proven experience in regulatory affairs, specifically in the maintenance and lifecycle management of marketed products.
  • European Regulatory Knowledge: Strong understanding of European regulatory landscape, procedural requirements, and guidelines.
  • Global Licensing Experience: Knowledge of licensing requirements in other regions (e.g., APAC, LATAM, MENA) is an advantage.
  • Skills:
    • Ability to work effectively in a complex environment.
    • Strong communication and influencing skills, with the ability to deliver clear, impactful messages.

Preferred Qualifications:

  • Matrix Working: Experience in fostering matrix collaboration, especially in virtual or remote teams.
  • Networking: Ability to develop networks within GSK to gain support for projects.
  • Decision Making: Skilled in evaluating risks and benefits before making key decisions.
  • Performance Improvement: Ability to challenge working practices and propose strategies for continuous improvement.

Why GSK?

At GSK, we offer:

  • Competitive Salary and Annual Bonus based on company performance.
  • Healthcare & Wellbeing Programs to support the health and well-being of our employees.
  • Pension Plan and Shares & Savings Program for financial security.
  • Hybrid Working model, promoting flexibility and work-life balance.

We foster an environment where people can grow, innovate, and contribute to making a difference in the world.


Equal Opportunity Employer

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.


How to Apply:

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.


Application Deadline:

January 28, 2025 (COB)


Important Notice to Employment Agencies:

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.