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Associate Regulatory Affairs Manager

  • Job reference: 931614
  • Location: Wokingham, Berkshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 06/08/2020

Orion Group Sciences have an exciting opportunity for an Associate Regulatory Affairs Manager for our multinational medical client based in the Berkshire area on an initial 4-month contract.

Requirements:

  • Drawing on relevant expertise and information from both internal and external sources, make a major contribution towards the preparation of any critical regulatory documentation for notifications in the Medical Device area.
  • Develop and support regulatory strategies in line with business plan.
  • Partner with brand and cross functional team to explore new and revised claims for advertising copy and pack that are within the framework of the product classification.
  • Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met.
  • Sign off packaging material, leaflets, and advertising /promo material to ensure regulatory compliances for submissions visa appropriate document approval systems.
  • Assist crisis management /PR matters as related to regulatory affairs.
  • Fulfil Department compliance obligations that include:
  • Processes, SOPs, working instructions adherence and ownership of processes for continuous improvement.
  • Update relevant, local and Global databases to track current product information and facilitate product notification under the Cosmetic Regulations
  • Support audit and inspections.
  • Provide regulatory advice and perform due diligence for product acquisitions and agreements with third parties
  • Maintain strong awareness of current regulatory requirements
  • Monitor changes in the regulatory environment and highlight any potential impact on the company products ,with an action plan where applicable
  • Represent Regulatory Affairs on cross functional product/project teams and provide regulatory advice and/or support (as appropriate) both internally and externally. Provide regulatory guidance to internal stakeholders, to allow them to make to key decisions on business critical activities and project feasibility.

Qualifications

  • Life Sciences, Chemistry degree or equivalent
  • Sound working Knowledge and experience of EU Cosmetics Regulations and associated UK requirements
  • Good grasp of the regulatory framework and borderline between medicines, Cosmetics and Medical Devices
  • An awareness and some working knowledge of Advertising copy approval requirements in the UK for example, CAP, BCAP and Advertising Standards Authority.
  • Excellent Leadership, communication and organisational Skills
  • Detail-oriented, effective in written and oral communication.
  • Works independently to plan, conduct and manager regulatory projects to meet department and company objectives
  • Responsible for identifying, implementing and managing key RA Departmental projects and/or strategies based on both short and long term RA Department objective.

For more information on this role, call Denise Cagney on +44 (0) 203 994 4695 or email Denise.Cagney@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number:


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 Associate
  • Salary Negotiable
  • Job type Contract
  • Location Wokingham, Berkshire
  • Description Orion Group Sciences have an exciting opportunity for a Regulatory Affairs Associate for our multinational medical client based in the Berkshire area on an initial 4-month contract