Head of Regulatory Affairs

**DESCRIPTION**:
Responsible for managing the product registration chain, compliance with all regulatory authorities and Global Regulatory Affairs guidance, maintenance of product licenses, and relevant Life Cycle Management (LCM) activities in ROPU ASKAN.

The position functions as the link between global RA functions and provides functional leadership to RA teams in ROPU ASKAN countries.

Responsible for pharmacovigilance (PV) of the Animal Health products and the ROPU PV system in compliance with local regulations and Global PV guidance, including training of all employees on PV responsibilities in ROPU ASKAN.
Contributing to the successful development of the Animal Health business by executing global and regional regulatory affairs (RA) strategies as well as managing local RA and pharmacovigilance (PV) teams and processes.

**DUTIES & RESPONSIBILITIES**
- Translate the Global Animal Health Regulatory Affairs Strategy into a ROPU Animal Health RA Strategy; Align the regional and local regulatory strategies and issues with other businesses/functions and monitor the implementation of ROPU RA strategy; Foster best practice, learning and knowledge sharing and synergies across the ROPU.
- Responsible for the management of product registration activities, in accordance with corporate policies and strategic direction of Global RA and according to the particularities and legislation required by ROPU ASKAN countries. Coordinates all involved functional and cross-functional stakeholders and proactively addresses critical topics, to ensure all milestones are kept and timely registrations/variations are ensured. Monitor regulatory and quality requirements and relevant legislation as well as a consequence assessment for the current Marketing Authorizations.
- Ensure internal support is provided to other departments (Marketing, Supply Chain and QA). Support technical documentation and knowledge for QA, the Local Advisory Committee (Product Recalls), and Supply Chain Management in the case of importation document requirements.
- Responsible for maintaining and updating the global RA databases. Lead and manage the activities of ROPU RA and OPU RA in order to obtain and maintain licenses, renewal and changes in product registrations.
- Monitors and improves a ROPU PV data collection and reporting system. Ensures correctness, completeness and reliability of PV information. Assessment/Global submission of AERs on time. Act as contact for Global PV and local health authorities.
- Ensures local PV training of all ROPU personnel and documentation thereof. Ensures presence of appropriate PV system and training.
- Representing the RA needs and local business related RA priorities in SBU and Global RA/R&D teams. Build, lead and manage the RA teams across ROPU ASKAN.

**REQUIREMENTS**:

- Masters degree (e.g. MSc) in Veterinary Medicine, Pharmacy or Human Medicine.
- Knowledge of Regulatory and pharmacovigilance policy, regulations and procedures. Good knowledge of pharmaceutical terminology and understanding of the development process of a Veterinary Medicinal Product through the system from the final development of the product, through the regulatory procedures at the authorities and final approval and launch of product.
- Solid experience in the pharmaceutical/life science/animal health industry
- Strong written & verbal communication skills along with excellent interpersonal skills and demonstrated ability to develop stakeholder relationships.
- Ability to lead and coordinate diverse groups of professionals.
- Demonstrated ability to lead, collaborate and deliver results in a highly matrix organization.

**Job Types**: Full-time, Permanent

Schedule:

- Day shift