Regulatory Affairs Manager
A global pharmaceutical company is currently recruiting a Regulatory Affairs Manager. Based in Switzerland, this is an exciting opportunity to bring expertise and skills to an established and in-demand company specialising in multiple therapy areas.
- Leading 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.
- Ensuring the compliance of registered products with local laws and requirements.
- Serving as the key liaison between the company and the local Health Authority and the Industry Associations.
- Building strong working relationships and conduct yourself with integrity with both internal and external stakeholders to protect and elevate the company's reputation.
- Striving for a performance-based culture and deliver operational excellence working in a cross-functional environment within R&D and the Commercial business based on the company's values of Patient, Trust, Reputation and Business.
- Coaching of Regulatory Managers (best practice sharing, support)
- New MA registrations provide RA input for launch strategy aligned with the commercial plan for timely submissions/approvals and management of national phases of Swiss Procedures.
- Maintaining relevant knowledge of the 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.
- Due diligence for locally in-licensed products from RA perspective including support for MA Transfers.
- MA lifecycle maintenance incl. renewals, variations (CMC and non-CMC), labelling updates, blue box requirements, PSUR/PBRERs etc.
- Ensuring 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)
- Maintain Global and Local Regulatory databases to ensure accurate records of Regulatory activity and data archives as a key priority.
- Contributing to Regulatory Intelligence, stay up to date on local and EU laws and assess the impact on local business and products.
- Compliance with EU and local laws and the company's internal processes including EU Food Supplements, Medical Devices, Cosmetics Directives.
- Building relationships with Health Authorities, understand their internal workings, maintain open communication channels and respond with urgency and accuracy to Health Authority requests.
- Active involvement and participation at the Industry Associations.
- Promoting, encouraging and demonstrating commitment to the company.
- Budget planning, managing RA contractors/CROs and oversight of outsourced RA activities in agreement with RA Switzerland Lead.
- Responsible for Release of promotional materials and their monitoring for conformity and compliance with regulatory requirements
- Owner and Administrator of the new clearing tool Zinc Map (future tool Promo Mats).
Skills and Requirements:
- University degree in Pharmacy or other scientific studies.
- Minimum of 5 years of experience in RA.
- Minimum of 5 years of experience in the pharmaceutical industry.
- In-depth knowledge of applicable laws, regulations and codices for the pharmaceutical industry.
- Innovative and develops new ways of working and uses these to differentiate from the competition.
- Builds a collaborative network of relationships with people in a variety of functions, roles and locations and leverages formal and informal networks to accomplish the ambitious goals.
- Strong ability to assimilate information (technical, clinical, medical, scientific) quickly, present clinical data clearly and concisely and discuss the statistical and clinical relevance in line with key messages.
- Project management skills to deliver within set time frames.
- Strong communicator with the ability to engage both external and internal customers.
- Fluent written & spoken German & English / additional national language is a plus (French / Italian).
- Proficient in computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Anna Bigiotti at 0203 854 2470 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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