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Regulatory Affairs Manager

  • Job reference: 922829
  • Location: Uxbridge, Middlesex
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 30/11/2018

Orion Group are recruiting for a Regulatory Affairs Manager for our multinational bio-pharmaceutical client based in the Middlesex area on an initial 12 month contract. There is also flexibility to be based out of the Cambridgeshire area.

This role will support one or more products from a regional (extended Europe) regulatory perspective. The incumbent will ensure that the company acquires and maintains all the required licenses in order to support clinical trials and further development of investigational medicinal products; market commercially approved medicinal products as well as regulatory compliance, with a focus on patient safety. Role is focussed on developing and executing regulatory strategy in the EU Oncology background is ideal.

Responsibilities of the role:
Strategy and Execution
* Plans and manages regulatory submissions for products within the company's portfolio in compliance with global filing plans and local regulatory requirements.
* Under general supervision, implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
* Provides content guidance for regional regulatory documents and meetings in accordance with global strategy
* Provides regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans)
* Supports regional label negotiation activities
* Under general supervision participate in the development, and execution of regional regulatory product strategies
* Ensures regional needs are well defined and implemented in collaboration with relevant regional cross-functional stakeholders
* Communicates regulatory strategies within team
* Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies
* Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to the company products.
* Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product development.
* Under supervision evaluates and communicate impact of relevant regional regulations, guidance, current regulatory environment and competitor labelling

Desired skillset and background of the successful candidate:

* Scientific Degree and demonstrated experience in a similar role
* Regulatory principles
o Working with policies, procedures and SOP's
o Knowledge of legislation and regulations relating to medicinal products
o Awareness of the registration procedures in region for development, MA, post approval changes, extensions and renewals.
* Knowledge of drug development
* Knowledge of and experience in regional regulatory environment
* Team work
* Communication skills - both oral and written
* Ability to understand and communicate scientific/clinical information
* Ability to anticipate and prevent potential issues
* Ability to resolve conflicts and develop a course of action leading to a beneficial outcome

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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