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Job Details

Regulatory Affairs Manager - Belgium

Company: Key People Limited
Location: Brussels
Reference: BBBH23227
Closing Date: 19 Jun 18
Type: Permanent
Salary (£): 40,000 - 60,000
Benefits:

Job Summary:

An excellent opportunity has arisen for a Regulatory Specialist / Manager to join a Belgium based generics' company on a permanent basis. It is essential that the successful applicant has experience registering and maintaining licences with the Belgium authorities and have fluent Flemmish, French and English language skills.

Requirements:

An excellent opportunity has arisen for a Regulatory Specialist / Manager to join a Belgium based generics’ company on a permanent basis. It is essential that the successful applicant has experience registering and maintaining licences with the Belgium authorities and have fluent Flemmish, French and English language skills.

Major tasks and duties in collaboration with internal and external partners:

1. Conducting registration procedures to obtain registrations for medicines (mainly pharmaceuticals products, also veterinary and OTC) in line with local legislation
2. Maintenance of existing registrations (variations, renewals), maintenance of regulatory data-bases
3. Monitoring of local pharmaceutical legislation and monitoring the practice and trends of the Belgium medicine agency
4. Participating in the preparation of regulatory strategy for Belgium together with global regulatory strategy of the company
5. Planning coordinating and supervising all activities needed for obtaining marketing authorizations
6. Communication with local authorities
7. Working closely with Regulatory affairs headquarters and reporting to them
8. Translations of SPCs and leaflets to German, French and Dutch.
9. Preparation and implementation of SOPs and work instructions in line with global policy and local requirements for regulatory and QA fields
10. Close work with management and marketing for evaluation of new products
11. Responsible for Information and Publicity: a plus if (s)he has the RIP approval, (s)he will be involved in all tasks of the RIP
12. Submitting pharmacovigilance documentation to the relevant state institutions and transfer of received pharmacovigilance information to the qualified person responsible for pharmacovigilance in HQ
13. Plan, coordinate and supervise price and reimbursement activity.
14. Approving the artworks before the production

Experience required:
1. Pharmacy or life science degree
2. 1-5 years of experience in management of regulatory affairs/market access desired in international company
3. Some experience in pharmacovigilance
4. Knowledge of local and international regulatory procedures and relevant legislation (Registration and Price and Reimbursement procedures)
5. experiences working with local authorities in Belgium
6. Good presentation, communication and relationship skills
7. IT knowledge (relevant database systems)
8. Fluent in English, French and Dutch (speaking, reading and writing) if possible.

For further details about this role, or for a confidential conversation about other opportunities within regulatory, please send Tim Barratt a copy of your CV to tbarratt@keypeople.co.uk or call +44(0)1727 817 626.

Apply for this job: Regulatory Affairs Manager - Belgium

Contact Information:

Address:  Head Office
Catherine House
Adelaide Street
St Albans
Hertfordshire
AL3 5BA
England
Tel:  Tel: 44 (0) 1727 811634
Fax:  Fax: 44 (0) 1727 844838
Website:  Visit Our Web Site

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