This Position is based in Germany
Qualifications & Experience:
- Bachelors or Post Graduate degree in Pharmacy;
- Minimum 6 to 10 years experience in a Regulatory Affairs Department in a reputed pharmaceutical company working in senior position for last 2 years;
- Experience within Europe essential – broad East European experience is an advantage;
- Exposure and experience in dealing with multiple European markets directly as well as central EU submissions;
- Multilingual candidate would be a preference;
- Strong track record of registrations archived in European markets.
Specific Outcomes / Accountability:
- Receive new dossiers for submission, finalise and submit under Aspen EU;
- Liaise with distribution partners as to regulatory status of relevant filings;
- Assist with launch of these products through the Aspen Group, including packaging review and sign off.
- Ensure information included in the PV group for products launched;
- Ensure distributors are adequately licensed to sell products;
- Advising EU quality of new sites under registration and ensure audits are effected;
- Determine requirements for change control from each territory when requested by Group and manage variation submissions through Europe;
- Keep the Aspen Group updated as to requirements in markets and assist with these requirements when global strategies are being developed;
- Liaise with Quality and Pharmacovigilance to understand the status of products and feedback to Group;
- Liaise with distributors and provide feedback to Group;
- Attend to new product registrations in the region of the Aspen Global/Pharmacare products;
- Ensure all variations are submitted and approved for Aspen Global/Pharmacare products within timeframes that do not allow for disruption of supply;
- Ensure that the regulatory strategy is fully integrated with the commercial and supply chain strategies.
Please send your CV's to Roxanne at
assist@hcrecruit.co.za
Visit our website
www.hcrecruit.co.za and follow us on Facebook!
