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Regulatory Strategist Senior Manager

Employer
Pfizer
Location
Tadworth
Salary
Negotiable
Closing date
9 Jun 2022

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Sector
Science & Pharmaceuticals
Hours
Full Time
Flexibility
Home working available
Contract Type
Permanent

Job Details

This position will be responsible for creation, evaluation, and recommendation of European and Rest of World (ROW) regulatory strategies and tactics to support achievement of the project goals. Through their membership on the relevant clinical study team(s), they will assist in the development of program's European and ROW regulatory plan and its execution, identify and assess regulatory risks associated with planned regulatory and clinical development activities, and provide technical advice and counsel.


ROLE RESPONSIBILITIES

  • Support development of European and ROW regulatory strategy and tactics for the assigned product(s); contribute to ensuring that plans meet European and ROW regulatory requirements
  • Contribute to European and ROW Health Authority meeting planning, preparation and conduct
  • Member of European and ROW submission team(s) for assigned product(s)
  • Proactive identification and assessment of regulatory risks associated with planned clinical development activities
  • Development and oversight of submission content for submission dossiers, including European and ROW Clinical Trial Applications (CTAs), Pediatric Investigation Plans, Scientific Advice meeting materials, etc.
  • Review of submission documents and technical reports (e.g., clinical study protocols and reports, statistical analysis plans, investigator brochures, development safety update reports, etc.) for adherence to European and ROW regulatory guidelines, strategies, and commitments.
  • Provide advice to authors on the interpretation of templates (including internal and external regulatory guidelines) and the content of modules.
  • Draft regulatory documentation from approved sources. Review regulatory documentation for consistency and compliance with guidelines.
  • Coordinate responses to questions from European and ROW health authorities.
  • Liaise with internal clinical study teams and with external partners, such as contract research organizations and consultants
  • Other duties as necessary.

QUALIFICATIONS

  • Bachelor's degree required, with an advanced degree in science (MD, PhD, PharmD) preferred
  • Proven experience in Regulatory Affairs or other relevant industry experience
  • Experience in supporting submissions and reviews of MAA and/or major Type II variation applications via the EU Centralized Procedure
  • Demonstrated success in working in a matrix team and collaborating cross-functionally with clinical development, clinical operations, commercial, technical operations, pharm/tox, and medical affairs
  • Experience working with Regulatory Authorities in multiple territories is strongly preferred
  • Knowledge of regulatory requirements, including ICH requirements and regional requirements for global territories and an understanding of current global and regional trends in Regulatory Affairs.
  • Knowledge of the drug development process (early stage through commercialization and post-marketing)
  • Effective critical thinking, problem solving, and communication skills (verbal/written/email/presentation) with friendly and collaborative interpersonal skills; Global cross-functional/collaboration experience is a plus
  • Ability to communicate regulatory strategy to key stakeholders at clinical study team and submission team levels



The closing deadline for applications is May 24th.

All applicants must have the relevant authorisation to live and work in the UK / EU as applicable.


Company

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. 

In the UK, we have around 2,400 colleagues across four locations, working within our commercial business, research and development (R&D), manufacturing and distribution operations.

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