Regulatory Affairs Lead
An internationally leading pharmaceutical company is seeking to recruit a Regulatory Affairs Lead to join their office in Switzerland. Specialising in multiple therapy areas, the company boasts a superb pipeline with products that include treatments for diabetes, cancer and asthma. This is an exciting opportunity to work with a company that operates in over 90 countries across the globe.
- Leading the local Swiss overall 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 also the Industry Associations.
- Building strong working relationships and conducting yourself with integrity with both internal and external stakeholders to protect and elevate the company's reputation.
- Leading a highly effective team who strives 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 and facilitating the professional development of the team will be a high priority.
- 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.
- Maintaining relevant knowledge of the company's pipeline.
- Ensuring RA support for local product launches and early access programs.
- Collaborating with Market Access and Health Economics teams on the evidence generation and value proposition strategy including preparation of the Pricing and Reimbursement Dossier (HTA).
- Ensuring national registrations are aligned with global dossier updates.
- Providing relevant local impact assessments for global dossier changes.
- 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).
- Ensuring permanent inspection-readiness of RA function in accordance with local regulations and the company's internal processes.
- Primary contact for regulatory health authorities (HA) in national procedures and post-approval.
- Building relationships with HA, understanding their internal workings, maintaining open communication channels and responding with urgency and accuracy to Health Authority requests.
- Active involvement and participation at Industry Associations where possible.
- Ensuring conformity of products with EU and local laws and the company's internal processes including Medicinal Products, Food Supplements, Medical Devices and Cosmetics Directives.
- Maintaining Global and Local Regulatory databases to ensure accurate records of Regulatory activity.
- Contributing to Regulatory Intelligence, monitor local regulations and assess the impact on local business and products.
- Ensuring regulatory review of promotional materials.
- Providing leadership to a team of RA professionals located within the LOC. Accountable for goal setting, performance & workload monitoring, resourcing, staff hiring, training, and budget planning.
- Assigning product responsibilities in the team, manage RA contractors/CROs and ensuring oversight of outsourced RA activity.
Skills and Requirements:
- Higher degree in related scientific disciplines (pharmacy, biochemistry, biology).
- Minimum 8 years of experience in Pharmaceutical Regulatory Affairs, including QA/QP (FvP) and PV experience.
- Expert in RA with deep QA and PV knowledge.
- In-depth knowledge of applicable laws, regulations and codices for the pharmaceutical industry.
- Knowledge of the national and EU pharmaceutical legislation.
- Understanding of Drug Development and Marketing processes and requirements.
- Strong scientific background.
- Proven interpersonal, communication, analytical, and organisational skills.
- Ability to challenge self and others to overcome barriers and deliver high-quality solutions.
- Able to drive alignment between functional and commercial objectives.
- Strong negotiation skills and project management competencies.
- Mature professional presence & credibility.
- Ability to work under pressure.
- Fluent written and spoken German, French & English / Italian as additional national language is a plus.
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 Kelechi Dyke Senior Consultant at 0203 854 0200 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.