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Regulatory Affairs Manager

4 weeks ago

London, Greater London, United Kingdom Sinclair Full time
Job Description:

About the Role:

Sinclair is seeking a skilled Regulatory Affairs Manager to lead our Post Market Regulatory Affairs Team. In this position, you will oversee product market approvals in line with global regulatory standards and internal policies.

As a key member of our team, you will collaborate closely with our Injectables manufacturers, Business, and Commercial teams to achieve key performance indicators and strategic goals.

This role offers a unique opportunity to drive and enhance Post Market Regulatory processes, improving quality and efficiency throughout the organisation.

Key Responsibilities:

  1. Lead the Corporate Post Market Regulatory Affairs Team, providing expert knowledge and guidance supporting the interpretation and implementation of regulatory legislation and guidelines for devices in global territories.
  2. Mentor, coach, and develop team members, define performance goals and targets, conduct performance reviews, and regular 1:1s to manage toward achieving team goals.
  3. Identify and participate in appropriate training events and activities to ensure personal development within the field of post market regulatory affairs.
  4. Implement appropriate post market regulatory strategies to achieve further approvals for company's products in global territories.
  5. Work with in-country distributors or contractors to determine regulatory requirements for product registrations in those regions.
  6. Communicate to management any identified delays that may impact business expectations.
  7. Interact with regulatory consultants, regulatory and trade associates, and other third-party service providers to ensure their provision of any requested activities to agreed timescales.
  8. Provide relevant regulatory advice and guidance to assist other Sinclair personnel in the performance of their roles and responsibilities.
  9. Review and approve product artworks and partner marketing material according to the applicable regulations.
  10. Maintain all submission documents, shared drive folders, and databases in an accurate, complete, and timely manner to ensure prompt and accurate access to company regulatory information.
  11. Input into budgeting review specifically with reference to global post market regulatory requirements.
  12. Ensure purchase orders for global activities are raised as necessary and manage invoices for relevant projects.
  13. Maintain monthly business reports as necessary.
  14. Liaise with and assist Corporate Vigilance Team with respect to vigilance requirements of product dossiers and post marketing activities where necessary.
  15. Facilitate agreement between Sinclair Pharmaceuticals Ltd Legal and in-market partners regarding PoA/LoA expectations.
  16. Provide technical/regulatory input to Change Control Post Market Regulatory Assessments (RoW) and associated RCN/RFRI.
  17. Ensure preparation and maintenance of local market Site/Plant Master Files (SMF/PMF) for Sinclair affiliate sites.
  18. Provide Post Market Regulatory support to the global EU MDR Strategy to ensure post market activities are planned and executed as part of the implementation processes.

Requirements:

  • University Degree in a scientific field
  • Minimum 6 years' experience in Post Market Regulatory Affairs Management within a Medical Device or Aesthetics organisation
  • Working knowledge of the Medical Device Regulation
  • Knowledge of other regulatory legislation and guidelines
  • Organised, target-oriented, flexible, good time management skills
  • Fluency in written and spoken English

What We Offer:

  • 25 days annual leave (plus bank holidays)
  • Bonus based on performance
  • Free parking
  • Company pension scheme
  • Private medical insurance
  • Healthcare Cash plan
  • Employee Assistance Programme
  • Store discounts
  • Tech and Cycle Scheme
  • Discounted dining card
  • Cycle to work scheme
  • Green car scheme
  • Holiday buy and sell
  • Life Assurance scheme