Regulatory Affairs Lead (m/f/d)

REFERENCE NUMBER:

465106/1

MY DUTIES:

- Accountable for local Regulatory Affairs (RA) input into submission and launch strategy, aligned with commercial plan, and for timely submission and approval of marketing authorisation applications, variations and renewals. Maintain relevant knowledge of company’s pipeline
- Ensure RA support for local product launches and early access programs and collaborate with Market Access and Health Economics teams on the evidence generation and value proposition strategy including preparation of the Pricing and Reimbursement Dossier (HTA)
- MA lifecycle maintenance incl. renewals, variations (CMC and non-CMC), labeling updates, PSUR/PBRERs etc. and ensure national registrations are aligned with global dossier updates. Provide relevant local impact assessments for global dossier changes
- Due diligence for locally in-licensed products from RA perspective including support for MA transfers
- Manage 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) and ensure permanent inspection-readiness of RA function in accordance with local regulations and internal processes 
- Be the primary contact for regulatory health authorities (HA) in national procedures and post-approval and build relationships with HA, understand their internal workings, maintain open communication channels and respond with urgency and accuracy to Health Authority requests
- Active involvement and participation at Industry Associations where possible
- Ensure conformity of products with EU and local laws and internal processes including Medicinal Products, Food Supplements, Medical Devices, Cosmetics Directives
- Maintain Global and Local Regulatory databases to ensure accurate records of Regulatory activity
- Provide leadership to a team of RA professionals located within the LOC. Accountable for goal setting, performance and workload monitoring, resourcing, staff hiring, training, and budget planning 
- Assign product responsibilities in the team, manage RA contractors/CROs and ensure oversight of outsourced RA activity
- Ensure alignment of RA Team focus with global R&D strategies and LOC business priorities. Support continuous improvement and process simplification in collaboration with EU RA leadership and local partners
- Ensure regular and ad hoc presentation of RA topics to the LOC country leadership team and help ensure “One R&D voice” is delivered in the LOC. Represent the country at European/Global RA level

MY QUALIFICATIONS:

- Knowledge of the national and EU pharmaceutical legislation
- Understanding of Drug Development and Marketing processes and requirements
- Proven interpersonal, communication, analytical, and organizational skills
- Higher degree in related scientific disciplines (pharmacy, biochemistry, biology)
- Profound experience in Pharmaceutical Regulatory Affairs, including QA/QP (FvP) and PV experience
- Expert in RA with in-depth QA and PV knowledge
- In-depth knowledge of applicable laws, regulations and codices for pharmaceutical industry
- Fluent written and  spoken German, French and English / Italian as additional national language is a plus

MY BENEFITS:

- Reputable / modern company

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Yves Fabien Deschamps

Reference number
465106/1

Contact
E-Mail: [email protected]