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Regulatory Affairs Associate - United Kingdom
Want to know company name or location? Company managed [?]
Posted on : 14 May 2017
- We are currently hiring for a 6 months fixed term contractor.
- This will suit a candidate with 1-2 years Regulatory Affairs experience within a Pharmaceutical or Medical Device environment.
- This role is in place to support commercialization of our company’s diverse portfolio of medicinal products, medical devices, food supplements, biocides and cosmetics in export markets (mainly non-EU markets where our company operates via distributors) and support 3rd party contract business within and outside Europe , with significant potential to make a meaningful difference to the business.
- The role will focus on execution of already defined strategies and supporting strategy development and implementation, working with a complex network of stakeholders, to achieve timely registration consistent with business expectations and support life cycle maintenance and compliance.
- This person will be an integral part of the International Contract and Export (ICE) Regulatory Affairs Team, as a contractor for a temporary time.
- Strategy support: Assess regulatory dossiers suitability for use in the export markets and liaise with local distribution partners to understand market specific needs and requirements. Assist the relevant senior associate or project manager to develop innovative regulatory strategies across multiple product types, to deliver timely registration
- Implementation: Execute the implementation/delivery of the regulatory strategy, working closely with both local distribution partners and internal stakeholders.
- Stakeholder Management: Work in close collaboration with stakeholders around the world as well as internal functions
- Operational: Understand and follow procedures relating to export regulatory deliverables to contribute to the growing operational framework within the Global Regulatory Team and report deviations from the processes.
- Provide regulatory support for our company 3rd party contract business.
- Preparation and submission of new registration packages, renewal packages and variation packages. This requires to liaise with the distributors, contract manufacturing plants, with relevant internal functions and also with affiliates if necessary.
- Provide support for replying to RA questions raised by local Health Authorities, via local distribution partners, or other relevant stakeholders.
- Validation of packaging materials.
- Keep the internal Regulatory Affairs databases and relevant trackers up-to-date.
- Gather information and documents from external and internal stakeholders
Education & experience required
- Educated within life sciences
- 1-2 years experience working within medicines regulatory affairs, ideally within OTC and substance based medical devices regulatory affairs
- Ideal: Hands on experience with biocide, cosmetics and food supplements regulatory affairs, Minimum: Basic understanding of biocide, cosmetics and food supplements regulatory affairs
- Experience in regulatory affairs in export markets (outside the EU)
- Basic understanding of EU regulatory requirements and processes