Accessibility Links

Regulatory Affairs Associate

  • Job reference: 931741
  • Location: Wokingham, Berkshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 19/08/2020

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.

KEY RESPONSIBILITIES

  • Management of a product or specified products within a therapy area for Cosmetics, OTC and/or Medical Devices
  • Supports the Northern Cluster team (as appropriate) for UK, Ireland and Malta products across the Company portfolio range.
  • Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area
  • Supports the team with regulatory activities for National and/or European procedures (Decentralised, Mutual Recognition) as appropriate.
  • Supports the team with regulatory strategies (local and regional) in line with business plan.
  • Supports the team to complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
  • Prepares and compiles regulatory submissions (Marketing Authorisations, Reclassifications etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU regulations and guidelines.
  • Sign off of packaging material, leaflets, SmPCs and advertising material (as appropriate) to ensure regulatory compliance for submissions via Zinc, COCOON, Starfish systems etc.
  • Ensure Marketing Authorisations are maintained and renewed.
  • Inform the Regulatory Agency/Department of Health (as appropriate) of product discontinuations and licence cancellations.
  • Ensures compliance within the department by ensuring
  • Global, EAME and local databases are fully maintained.
  • Processes, SOPs, working instructions and Job Aids are adhered to.
  • Update relevant local and global databases (e.g Documentum, Aris, Connect etc.) to track current product information.
  • Provides regulatory advice and performs due diligence for product acquisitions and distributor agreements with third parties (as appropriate).
  • Good Regulatory Practice
  • Maintain awareness/knowledge of current regulatory legislation.
  • Ensures regulatory best practice at all times.
  • Monitor changes in the regulatory environment and highlight any potential impact it would have on the Company.

Customer Service

  • May act as an ambassador for the Regulatory Affairs department to raise profile of team both internally and externally.
  • May represent Regulatory Affairs on cross-functional product/project teams and provides regulatory advice (as appropriate).
  • Interactions with Regulatory Agency

Note, if an individual is to have full interaction with the Health Authorities and respond to submissions on behalf of the Company, then the HCBI due diligence process must be completed prior to an individual having this contact.

  • Seek advice when appropriate.
  • Respond to requests for further information and queries.
  • Resolve any regulatory matters and expedite approval of pending applications.
  • Provides regulatory guidance to internal stakeholders, to allow them make key decisions on business critical activities and project feasibility.
  • If required, represent the Company and provide regulatory advice at e.g. joint Company/Trade Association initiatives, Regulatory Agency meetings etc (as appropriate).

Personal Development

  • Complete induction programme in line within the defined timelines.
  • Develop product and therapeutic area knowledge as needed.
  • Ensure that any processes or SOPs/working instructions/ job aids roll outs are actioned in Compliance Wire and within the defined timeline.
  • Maintains training record (as appropriate).

QUALIFICATIONS & EXPERIENCE

  • Generally Requires 2-4 Years Work Experience
  • Life sciences or chemistry graduate to honours level or equivalent.
  • Works with minimal supervision to plan, conduct, and manage regulatory submissions and multiple projects to meet department and company objectives.
  • Work with minimal supervision to determine and develop approaches to solutions with technical guidance on a variety of problems of moderate scope and complexity.
  • May mentor Graduate and Regulatory Executive and provide day to day support (as appropriate).
  • Project management, understanding of regulatory environment, interaction with the Regulatory Authorities (as appropriate), commercial / strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations etc

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.