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Senior Global Program Regulatory Manager - Paddington, London (Hybrid)

Contract: Permanent Career Opportunity

Closing Date: 26/07/24

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The Senior Global Program Regulatory Manager works under limited supervision of the regulatory affairs (RA) program lead to develop and implement the global regulatory strategy for the program through development, registration, and post-approval in the assigned region.

The Senior Global Program Regulatory Manager may act as the RA program lead on programs of limited complexity.

The Senior Global Program Regulatory Manager is a member of the RA sub-team and may lead or represent RA in regional or cross-functional teams.

The Role

Duties may include:

Regulatory Strategy

  • Provides input to global program regulatory strategy, including regulatory designations & innovative approaches
  • May provide global RA leadership for specific parts of the program e.g. new indication, new formulation, or act as RA program lead for the program of limited complexity
  • Coordinates regulatory readiness with other line functions, Country Organizations & Regions
  • Represents RA or leads in regional RA or cross-functional activities
  • Provides strategic input to cross-functional deliverables (e.g. protocols, IB, safety reports, etc)
  • Contributes to the development and maintenance of the Core Data Sheet (CDS)
  • Determines requirements and coordinates activities for Health Authority (HA) interactions. May lead HAs meetings together with RA program lead.
  • May serve as local HA liaison (e.g., FDA or EMA).

Regulatory Submissions

  • Leads planning, preparation, and submission of clinical trials.
  • Leads implementation of the defined global registration strategy into regional submissions worldwide by country organizations.
  • Coordinates, plans, and prepares for submission of initial registration and post-approval applications, including authoring of Module 1 documents.
  • Contribute to the preparation, review, and maintenance of local product information in their assigned region.
  • Leads regulatory activities during HA reviews including responses to questions and HA interactions.

Regulatory Excellence and Compliance

  • Ensures timely RA input and submission of regulatory compliance and maintenance reports (e.g. aggregate safety reports, annual reports, renewals, etc) across assigned regions.
  • Maintains regulatory information in compliance databases and document management systems.
  • May serve as RA subject matter expert.
  • May assume a mentoring role.

Life cycle management

  • In LCM, the Sr GPRM may report to the LCM-(Sr)GPRD, and focus on one of the following subject matter expertise:
    • Maintenance: preparation of selected global regulatory submissions (eg Annual, aggregate safety reports, renewals, variations, etc.) for assigned portfolio.
    • Portfolio Transformation: portfolio streamlining activities eg. pruning and de-registration, divestment/integration, RxGx, portfolio transformation, and manufacturing production transfer as applicable.
    • Business & Operational Excellence: Procurement of key components e.g. registration samples, certificates of pharmaceutical product CPPs, etc. in support of regional regulatory submissions.

Requirements

  • Science-based BS or MS. Advanced degree (e.g., MD, PhD, PharmD, regulatory) preferred
  • Advanced understanding of pharmaceutical development, clinical trials, analysis, and interpretation of scientific data
  • Awareness of post-marketing/brand optimization strategies and commercial aspects.
  • A minimum of 4 years of involvement in regulatory and pharmaceutical development spanning activities in Phases I-IV in 1 or more major regions.
  • Experience in leading cross-functional teams.
  • Strong collaboration, communication influencing, and problem-solving skills.
  • Organizational awareness (e.g., interrelationship of departments, business priorities).
  • Compliance and Quality mindset.
How to Apply

For further details, please send your CV to: talent@gandlhealth.com

G&L Healthcare Advisors is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status, or race.

We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.

G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment, and abuse. All employees at G&L share the responsibility to challenge discriminatory behavior and promote equality of opportunity.

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