EMEA Regulatory Professional

Location Beerse, Arrondissement Turnhout, Antwerp, Flanders
Discipline: Pharmaceutical
Job type: Temporary/Freelance
Contact name: Daria Petrova

Contact email: d.petrova@panda-int.com
Job ref: 13282
Published: about 1 month ago

I’m looking for a Regulatory Affairs 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.

PROFILE:

  • BSc medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
  • Experience in regulatory affairs
  • Project management skills
  • Knowledge of the regulatory environment, guidelines and practice of EMEA regions

RESPONSIBILITIES:
1. 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

5. Marketing Authorization Applications (MAA)

  • Provide regulatory support throughout registration process
  • Provide regulatory support throughout life-cycle management
  • Advise 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

LOCATION: remote
INTERESTED?

If you are interested in the above description, apply with your CV

PS: Did you also know that we offer an attractive referral scheme? Check this LINK

For more information please contact Daria Petrova on +31 (0)20 20 44 502