Regulatory Affairs Manager
Jocelyn Blackham is recruiting for a Regulatory Affairs Manager to join a leading pharmaceutical company at their site based in Zurich on a contract basis for 8 months.
The main purpose of the role will be to:
- Lead the local regulatory strategy working in collaboration with the Regional and Global Regulatory Leads to successfully deliver the product development and life cycle management plans in accordance with agreed business priorities. Also responsible for ensuring the compliance of registered products with local laws and requirements.
- Serve as the key liaison between the company and the local Health Authority and also the Industry Associations.
- Build strong working relationships with integrity with both internal and external stakeholders to protect and elevate the company's reputation.
Further responsibilities will include:
- Providing RA input for new MA registrations, for launch strategy aligned with commercial plan for timely submissions/approvals and management of national phases of Swiss Procedures. Maintain relevant knowledge of company's pipeline in relevant Therapy Area Units
- Collaborating with Market Access team on the evidence generation and value proposition strategy including preparation of the Pricing and Reimbursement Dossier and follow up Renewal applications
- MA lifecycle maintenance incl. renewals, variations (CMC and non-CMC), labeling updates, blue box requirements, PSUR/PBRERs and etc. Ensure national registrations are aligned with global dossier updates and take ownership of regulatory strategies for country specific National registrations. Provide relevant local impact assessments for global dossier changes and initiate change requests for national licenses as per change control processes.
- Managing compliance of labelling (and mock-ups) with CCDS (incl. updates for generics if originator product changes). Local translations of SmPC, labelling, patient information and distribution to internal and external stakeholders (incl. public lists, websites).
- Contributing to Regulatory Intelligence, stay up to date on local and EU laws and assess the impact on local business and products
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Previous experience within Regulatory Affairs within the pharmaceutical environment is essential
- BSc in Pharmacy or a related discipline, or equivalent
- Fluent written & spoken German & English / additional national language is a plus (French / Italian)
- In depth knowledge of applicable laws, regulations and codices for pharmaceutical industry
This is an excellent opportunity to join a growing pharmaceutical company.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 782 516 595 or email email@example.com. Please could you send any correspondence in English. Please quote reference 47569 in all correspondence.