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Regulatory Affairs Manager

  • Job reference: 928924
  • Location: Cambridge, Cambridgeshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 02/12/2019

Orion Group Sciences are looking for a Regulatory Affairs Manager for our multinational pharmaceutical client based in the Cambridgeshire area on an initial 12-month contract with the potential to extend.

Job Purpose
This role will support one or more products development and/or marketed products from a regional regulatory perspective. The purpose of this role is to ensure that the client acquires and maintains all the required approvals in order to support clinical trials for investigational medicinal products as well as to market approved medicinal products and to ensure timely regulatory compliance with above approvals.

Main Responsibilities of the role

  • Advising the regulatory team on regional considerations in developing strategy
  • Participating in core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy (under general supervision)
  • Providing regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and paediatric plans)
  • Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
  • Participating as a member of: Global Regulatory Team (GRT), Evidence Generation Team (EGT), Clinical Study Team (CST), Regional Teams
  • Acting as a contact with relevant regulatory agencies; documenting and communicating details and outcomes of regulatory agency interactions to GRT and relevant Management and Senior Management

Desired Experience and Background of the successful candidate

  • Knowledge of relevant legislation and regulations relating to medicinal products and of regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals
  • Knowledge of drug development
  • Working with policies, procedures and SOPs
  • Cultural awareness and sensitivity to achieve results across both regional country and international borders

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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Regulatory Affairs Manager 29779
  • Salary Negotiable
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  • Location Cambridge, Cambridgeshire
  • Description Orion Group are recruiting a Regulatory Affairs Manager on behalf of one of our Multinational Pharmaceutical Clients on an initial contract with potential to be extended in Cambridge Description: