Beschreibung
Job/Position: Regulatory Affairs Manager Location: Switzerland (Schwyz)Duration: 8 months (+ extension)
ROLE OBJECTIVE
- Taking part in 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.
- Handling communication between the company and the local Health Authority and also the Industry Associations. Building strong working relationships and conduct yourself with integrity with both internal and external stakeholders.
- 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.
- Final sign off for promotional material (werbeverantwortliche Person) and contact for science industries (Pharmacode-Office)
- Coaching of Regulatory Managers (best practice sharing, support)
ACCOUNTABILITIES
- For new MA registrations provide RA input 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
- Collaborate 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), 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.
- 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)
- Maintain Global and Local Regulatory databases to ensure accurate records of Regulatory activity and data archives as a key priority.
- Contribute 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 company's internal processes including EU Food Supplements, Medical Devices, Cosmetics Directives.
- Build 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 Industry Associations.
- 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 LEADERSHIP CAPABILITIES
- Innovative, develops new ways of working and uses these to differentiate from competition
- Strong communicator with the ability to engage both external and internal customers
- 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 & concisely and discuss the statistical and clinical relevance in line with key messages
- Project management skills - to deliver within set time frames
- Understanding the decision making units and an ability to manage complex networks
- Broad business acumen/understanding
- Professional presence & credibility
- Passionate & self-confident
- Ability to work under pressure
Experience and Education
- University degree in Pharmacy or other scientific studies
- Minimum 5 year experience in RA
- Minimum 5 years of experience in pharmaceutical industry
- In depth knowledge of applicable laws, regulations and codices for pharmaceutical industry
- Fluent written & spoken German & English / additional national language is a plus (French / Italian)
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.