EMEA Regulatory Manager

Location Beerse, Arrondissement Turnhout, Antwerp, Flanders
Discipline: Pharmaceutical
Contact name: Sayf Idais

Contact email: s.idais@panda-int.com
Job ref: 13348
Published: 21 days ago

For one of our key clients in the pharmaceutical industry, we are looking for a EMEA Regulatory Manager 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. This opportunity offers a 9-month contract with possible extension. The company is in Beerse, Belgium.

Responsibilities:

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

 

Requirements:

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

 

Project start date:

Short notice preferred

 

Project duration:

9 months + extension possible.

 

Interested?

If you are interested in the above description, please apply with your CV and a letter of motivation.

 

PS: Did you also know that we offer a generous referral scheme, because great people know other great people, right?

For further information, please contact Sayf Idais at +31 (0)20 20 44 502 or by email at s.idais@panda-int.com