BE - COM - Regulatory Affairs Officer
An internationally renowned pharmaceutical company is currently advertising an EMEA Regulatory Liaison to their office in Belgium. This top 10 pharma company works across multiple sectors, including medical devices, pharmaceutical research, and consumer health. The vacancy offers an exciting opportunity to work with a company with over 100,000 professionals around the globe.
- Advise the Project Team and/or Regional Therapeutic Area Leader on applicable regulatory issues, project-specific regulatory issues, and issues related to regional regulatory climates
- Develop a deep understanding of the regional regulatory environment, competitor intelligence and therapeutic area
- Provide input for developing and updating the Target EU SmPC based on an understanding of the implications of regional regulatory strategy for labelling
- Ensure appropriate implementation of scientific advice / Regulatory Agency comments into development and life-cycle management plan
- Liaison with Regulatory Agencies and Local Operating Companies
- Act as primary contact with EMEA. Work through LOC and/or CRO for National Regulatory Agencies contacts, as appropriate
- Ensure appropriate involvement and liaise with LOC regulatory affairs personnel to facilitate local Regulatory Agency meetings
- Ensure that issues raised by Regulatory Agencies are promptly and adequately addressed
- Negotiate labelling with Regulatory Agencies, going through each of the back-up strategies if necessary
- Provide input to and review submission documents to ensure that they are fit for purpose and support labelling statements as appropriate
- Define, generate and submit appropriate data-driven (regional/local) responses to Regulatory Agency questions
- Ensure necessary regulatory activities are planned and adequately tracked in company systems
- Clinical Trial Applications (CTA) Ensure protocols are developed in alignment with regional registration strategies to support registration, reimbursement and competitive labelling
- Advise team on required documents and submission strategies in preparation of CTA
- Ensure CTA submission packages are complete and available according to agreed timelines
- Provide regulatory support throughout life-cycle management
- Manage submissions, define submission plans, and advise team on required documents and submission strategies in preparation of MAAs (in collaboration with LOCs as appropriate)
- Determine resource requirements for assigned projects and anticipate needs for major filings
Skills and Requirements
- University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
- 3-5 years' experience minimum, additional is a bonus.
- Breadth of regulatory experience in drug development and commercialization (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas)
- Experience with EU regulatory procedures (CP, MRP, national)
- Experience in working in project teams and/or a matrix organization
- Negotiating and conflict handling skills
- People management and organisational skills
- Oral & written communication skills
- Previous J&J experience a bonus Knowledge
- Excellent knowledge of English (fluent)
Please click on the Apply button. Kindly include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Keri Marshall at 0207 440 0679 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.