The Head of RA will be respondible to build the Swiss RA departement and be part of the local leadership team.
Head of Regulatory Affairs (f/m/d)
Our client is a multinational pharmaceutical business that is currently building up operations in Switzerland.
- The RP is responsible for the direct technical supervision of the facilities and shall in particular ensure that medicines are handled appropriately within the facilities, as applicable.
- The RP ensures that released pharmaceutical products correspond to valid specifications and that their manufacturing complies with the GMP. The RP decides to release or reject a batch, independently from the management of the company. The RP can delegate the release/certification of medicinal products' batches to the Deputy RP.
- The RP is the main contact point in case of inspections by relevant health authorities and supervises the relevant corrective actions related to inspections.
- The RP coordinates and handles the external complaints for product released in Switzerland based on quality defects or adverse drug reaction. He has the competence to inform the national health authority accordingly (i.e. Swissmedic).
- The RP personally supervises the initiation, realization and the evaluation of product complaints and batch recalls in Switzerland.
- The RP is responsible for the creation and administration of quality-relevant documents, such as Quality Manual, Site Master File, SOPs, etc., as appropriate.
- The RP performs or oversees the audits of distributors in Switzerland.
- The RP ensures that the initial and continued training of the personnel is carried out according to the respective requirements with respect to the Quality Management System.
- The RP reviews and approves the Quality Agreements with third parties in Switzerland.
- Bachelor's degree in a scientific discipline or Pharm.D and a minimum of 10 years of successful experience in Regulatory Science and Quality Assurance (or Quality Control) experience in a pharmaceutical industry.
- The position also requires a minimum of 5 years of leadership experience as a Head Regulatory Affairs role and as RP or Deputy RP.
- Very good understanding and several years of experience in pharmaceutical industry in Regulatory, Supply Chain, Quality Control and/or Quality Assurance.
- Prior experience leading a Regulatory Affairs function, including the associated staff for a mid-sized organization.
- Prior experience in OTC market (or Mature Brand/Generic portfolio)
- Prior experience as main RP or Deputy RP, including releasing of batches onto the Swiss market.
- Direct contact and negotiation experience with Swiss competent authorities, including Swissmedic and Cantonal Pharmacist.
- Demonstrated track record of success building relationships with, and influencing, national health authorities, particularly in situations requiring direct interaction/negotiation.
- Demonstrated record of success in gaining regulatory approvals in Switzerland.
- Demonstrated leadership ability and experience managing, coaching and mentoring direct reports.
- Ability to influence without direct authority.
- Good negotiating and interpersonal skills, as well as an excellent verbal and written communication in German and English and ideally in French
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Ability to travel mainly in France and internationally (mainly in Japan), as needed
- interesting challenge for the candidate to develop personally and professionally
- being part of the local business leadership team
- competitive salary package