Exclusive Opportunity! Regulatory Affairs Specialist, Benelux - Perm - Brussels, Belgium
Are you a Regulatory Affairs professional looking for opportunities to work in a challenging professional environment? Are you a Trilingual (Dutch, French and English) speaker? For immediate consideration call Nikolay on +44(0)2072556665 or e-mail nikolay.dimitrov@secpharma.com
The Company:
My client is a large global pharmaceutical company with nearly 100 years of experience with innovation and leadership. The company has a growing portfolio of established products consisting of a large variety of medicinal products in different therapeutic areas. They are currently looking for an experienced Regulatory Affairs professional to join their International Regulatory Affairs team.
The Role:
As a Regulatory Affairs Specialist you will be Responsible for all regulatory aspects related to new registrations and life cycle management for a portfolio of injectable products across BeNeLux. In order to make an impression, you should be curious and proactive in your approach to the ever-changing world of Regulatory Affairs.
Responsibilities:
- Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations
- Review and evaluate technical and scientific data required for submissions
- Compile and prepare responses to questions from regulatory authorities
- Track the status and progress of regulatory documentation
- Assist in preparation and review of labeling, SOP's and other documents
- Autonomously compile regulatory documents for submission
- Represent or lead the RA function on assigned cross-functional project teams
- Establish appropriate communication within RA and other functions primarily at project level
- May provide direct supervision of individuals
Requirements:
- BSc/MSc/PhD in pharmacy or related scientific discipline.
- 4+ years of experience in (international) RA in a pharmaceutical company / CRO
- Sound knowledge of chemical/pharmaceutical aspects of regulatory affairs
- Trilingual Dutch / French / English are a MUST!
- Demonstrated interpersonal skills including strong negotiation skills
- Strong team spirit and team working skills
This is an excellent opportunity to work within a respected international healthcare company which has an excellent track record of supporting its employees through personal and professional development. On offer is a challenging career opportunity within a multicultural Regulatory team. The company prides itself with their great culture and support of the work-life balance. Is this the place for you?
Nikolay Dimitrov
Pharmaceutical Division
Tel:
+44 (0)20 7255 6665
+33 (0)170807489
+49 (0)69 222 22 888
+41 (0)44 580 3717
Email: Nikolay.Dimitrov@secpharma.com
Web: www.secrecruitment.com
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