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Global Program Regulatory Manager - Paddington, London (Hybrid)

Contract: Permanent Career Opportunity

Closing Date: 26/07/24

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

The GPRM 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:

Strategy

  • Provide input to global program regulatory strategy, including regulatory designations & innovative approaches.
  • Coordinate regulatory readiness with other line functions, Country Organizations & Regions.
  • Represent RA or lead regional or cross-functional activities.
  • Provide strategic input to cross-functional deliverables (e.g. protocols, IB, safety reports, etc).
  • Contribute to the development and maintenance of the Core Data Sheet (CDS).
  • Determine requirements and coordinate activities for Health Authority (HA) interactions.
  • May facilitate HAs meetings together with RA program lead.
  • May serve as local HA liaison (e.g., FDA or EMA).

Regulatory Submissions

  • Lead planning, preparation, and submission of clinical trials.
  • Lead implementation of the defined global registration strategy into regional submissions worldwide by country organizations.
  • Coordinate, plan, and prepare 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
  • Lead regulatory activities during HA reviews including responses to questions and HA interactions

Regulatory Excellence and Compliance

  • Ensure timely RA input and submission of regulatory compliance and maintenance reports (e.g. aggregate safety reports, annual reports, renewals, etc) across assigned regions
  • Maintain regulatory information in compliance databases and document management systems

Life cycle management

  • In LCM, the 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.
  • Understanding of pharmaceutical development, clinical trials, analysis, and interpretation of scientific data.
  • 2 years minimum experience in regulatory and pharmaceutical development in 1 or more major regions.
  • Experience in working in cross-functional teams.
  • Strong collaboration and communication, problem problem-solving skills.
  • Basic 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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