Regulatory Affairs Manager

Regulatory Affairs Manager
  • Competitive
  • Cambridge, Cambridgeshire, England, UK Cambridge Cambridgeshire UK CB2 1RE
Job Ref: J2162247
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 08 October 2021
SRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy in their Regulatory team.

SRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team on an initial 3 Month basis to be based at their office in Cambridge (with some flexibility for remote working).The Role:The Regulatory Affairs Manager will be accountable for contributions in the development and implementation of a new business critical regulatory requirements repository. The manager will possess excellent project management skills, have an understanding of regional regulatory drug development regulatory processes and strategies. The major elements of the project will be regulatory business process redesign and development, strategic content evaluation, design and restructure and the support the delivery of a proof of concept project. The individual will work closely with the project leader and with a matrix team of cross functional, marketing company and other relevant stakeholders. The individual needs excellent communication skills and be highly organised to deliver outputs in a fast moving project. Ideally will have worked across international regions with experience across the development process in the delivery of strategy submissions. Key Responsibilities:Project Management* Supports project management activities for the program.* Contributes to team meeting discussions and presents regular updates and proposals to the core team.* Works closely with subject matter experts to evaluate and develop project proposals against target aspirations evaluating potential issues and actively problem solving and suggesting mitigations.* Ensure appropriate x-functional consultation and input.* Accountable for the delivery of against project milestones.* Ensuring progress recorded against project plan milestones.Content Delivery and Proof of Concept Activities* Supports to design and development of the content of the new repository including mapping of regulatory requirements. * Working closely with IT Operations team.* Development, delivery and management of validation activities with marketing companies.* Support migration and user testing activities for the proof of concept activity* Input in to intelligence process design and development* Ownership and management of activities to ensure delivered successfully against milestones.Skills/Experience Required:* Bachelor's degree in a science related field and/or other appropriate knowledge/experience.* More than 5 years of experience or equivalent of regulatory drug development including product approval/launch. * Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority. * Proven project management experience.* Keen attention to detail and analytical approach.* Process development experience with training in lean sigma principles.* Ability to work strategically within a complex, business critical and high profile project development program.* Involvement in a regulatory system development project.* Must demonstrate competencies of - strategic thinking, innovation, initiative, leadership and excellent oral and written communication skills.If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441615077288

07/11/2021 10:25:47
GBP Hour
Contact Consultant:
Corinne Laurence

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