Randstad, as the EMEA Johnson & Johnson talent acquisition partner, is responsible for finding and contracting talent for the contingent roles at Johnson & Johnson. If you are selected for a role you will be engaged or employed by one of the Randstad recruitment companies in EMEA and will not be an employee of Johnson & Johnson.

Johnson & Johnson

Regulatory Affairs Consultant

Posted Jan 13, 2021
Job ID: JJJP00005484
Location
Maidenhead , Berkshire
Duration
6 months
(Feb 22, 2021 - Aug 21, 2021)
Hours/week
40 hrs/week
Payrate range
45 - 55 £/hr

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

We are currently recruiting for a Regulatory Affairs Consultant to join our contingent workforce.


Responsibilities:


  • Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within the relevant therapy area
  • Responsible for regulatory activities related to National and/or European procedures (Decentralised, Mutual Recognition) as appropriate.
  • Define regulatory strategies (local and regional) in line with business plan.
  • Complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
  • Prepares and compiles regulatory submissions (Marketing Authorisations Applications, Renewals Variations, Reclassifications etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU & UK regulations and guidelines. 
  • Sign off packaging material, leaflets, SmPCs and advertising material (as appropriate) to ensure regulatory compliance for submissions 
  • Ensure Marketing Authorisations are maintained and renewed, and sunset obligations are met
  • 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 to track current product information. 
  • Maintain awareness/knowledge of current regulatory guidance and legislation, in particular related to Brexit
  • Monitor changes in the regulatory environment and highlight any potential impact on McNeil Products Ltd / J&J products.


Experience and Key Competencies:


  • Life sciences or chemistry graduate to honours level or equivalent.
  • Must have UK market regulatory experience within pharmaceutical regulatory affairs and working with MHRA directly, ideally with some OTC experience
  • Brexit related regulatory knowledge and experience 
  • Must have hands on experience in management of day to day UK and EU regulatory procedures 
  • Ideally knowledge and experience of allied regulatory affairs areas such as Cosmetic, Medical Devices but not essential 
  • 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 including processes
  • 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


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