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

EMEA Regulatory Professional

Posted Jan 15, 2021
Job ID: JJJP00005528
Location
High Wycombe
Duration
9 months
(Mar 15, 2021 - Dec 31, 2021)
Hours/week
37 hrs/week
Payrate range
40 - 45 £/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 EMEA Regulatory Professional who can support the regional regulatory strategy for products in the oncology pipeline, preferably with experience of clinical trial applications, scientific advice procedures, paediatric investigational plans or EU marketing authorisation applications and variations. 


Responsibilities:


 Input in development, post-approval and Life cycle management:

  • Participate in global regulatory team meetings as appropriate
  • Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
  • Have an understanding of the regional regulatory environment, and able to develop understand competitor intelligence and therapeutic area


2. Liaison with Regulatory Agencies and Local Operating Companies:

  • Act as back-up for contact with Regulatory Agencies as needed
  • Draft cover letters for Regulatory Agency communication
  • Assist in the preparation of meetings with Regulatory Agencies
  • Liaise with LOCs, track and respond to queries in a timely manner


3. Input in document and process development:

  • Assist in development of processes related to regulatory submissions
  • Draft and review some document content (depending on level of regulatory knowledge / expertise)
  • Provide input to documentation to ensure they thoroughly and accurately answer the questions being posed
  • Track dates of submissions and Regulatory Agency responses


4. Clinical Trial Applications (CTA):

  • Review protocols and ensure alignment with regulatory requirements
Advise team on required documents and submission strategies in preparation of CTAs
  • Ensure CTA submission packages are complete and available according to agreed timelines
  • Review and approve clinical trial supply plans


  1. Marketing Authorization Applications (MAA):
Provide regulatory support throughout registration processProvide regulatory support throughout life-cycle managementAdvise team on required documents and submission strategies in preparation of MAA as assigned (in collaboration with LOCs as appropriate)
  • Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities
  • Assist with submission and acceptance of MAA
Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans


Experience and Key Competencies:


  • University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
  • Experience in regulatory affairs
  • Project management skills
  • Organization & multi-tasking skills
  • Knowledge of the regulatory environment, guidelines and practice of EMEA regions


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