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Head of Regulatory Affairs

2 weeks ago

Bracknell Forest, United Kingdom BI AH UK Ltd Full time

**THE POSITION**:
**TASKS & RESPONSIBILITIES**:

- Accountable for the assembly, submission and follow through of regulatory submissions to obtain and maintain Marketing Authorisations and other necessary licences for UK, Ireland and Malta
- Provide regulatory intelligence and advice on regulatory status and requirements, including new developments to relevant internal local and corporate functions
- Accountable for pharmacovigilance reporting including managing the reporting of technical complaints, adverse events (AEs) and the submission of PSURs
- Accountable for the review of local marketing and technical materials and concepts from the regulatory perspective with respect to compliance under NOAH and APHA codes of practice
- Develop a skilled,competent and highly motivated Regulatory Affairs and Pharmacovigilance team
- To answer the demands of regulatory authorities, as well as processes and activities of the department in accordance with current policies and legislation; Ensure there is management of information and regulatory dossiers in order to ensure confidentiality, information protection and agility to provide information.
- Organise and update status of the registration process to relevant stakeholders
- Develop and maintain proactive relations with the authorities responsible for regulatory affairs in the UK and Ireland as well as stakeholders and influencers
- Accountable for the LCM activities in compliance with the existing legislation and policies, representing the regulatory needs and priorities of local business and cooperating with global teams

**REQUIREMENTS**:

- Significant Regulatory and Pharmacovigilance management experience
- Experience in Animal Health Regulatory environment with demonstrable network of external key stakeholders.
- Assertive confident credible communicator
- Skilled at developing positive working relationship and influencing others
- In depth knowledge of local and European regulatory affairs legislation and guidance

**WHY THIS IS A GREAT PLACE TO WORK**:
**CLOSING DATE: 16TH AUGUST**: