BAP Pharma are Global Leaders in Clinical Trials supply, specialising in comparator sourcing and secondary packaging. Founded in 2011, BAP Pharma is an incredible story of growth and success, steadily expanding its operations, with a presence in the UK, USA and Germany.
We are a team of professionals who have a passion for delivering on our promises to each other and our customers. We are driven to create exceptional value and an unrivalled service. Our culture is one of openness, honesty, and respect. Our goal is to become a Global Leader in the Clinical Trials Supply Industry.
We are now looking for people with a passion for great customer service and doing the right thing, to help us take the business forward. Our people are our greatest asset, our future is exciting, come join us!
The Regulatory Affairs Manager will conduct all associated regulatory activities for all markets globally. The role will also contribute to the implementation, leading of projects and building of expertise within the Unlicensed Medicines space.
- Contribute to Cross-functional Teams and Build Regulatory Expertise and provide regular updates
- Utilise regulatory expertise to develop and deliver optimal regulatory strategies and plans to support the achievement of country business goals for unlicensed supply globally of products on behalf of clients
- Attend relevant team and client meetings with cross-divisional colleagues to provide technical guidance and support for teams as necessary
- Ensure teams understand the potential opportunities and constraints that the latest legislation/upcoming changes to legislation might create for their commercial activities
- Provide regulatory input to commercial strategic and operating planning process
- Use knowledge of EU/national legislation, guidelines, regulatory environment to provide insightful responses to enquiries from cross-divisional colleagues and direct or indirect interactions with external customers
- Advise on matters of compliance, regulatory requirements and regulatory policy
- Partner with above-country operational hubs to prepare and collate information needed for contribution to departmental and ad hoc reports
- Seek authority advice/clarification if regulatory position is unclear and answers are not available through internal network
- Respond to requests from authorities promptly and accurately
- Proactively take opportunities to develop or enhance working relationships with Regulatory Authorities and trade associations
- Develop and enact appropriate strategies in order to negotiate optimal outcomes for the business and patient on product issues
- Utilise local knowledge of Regulatory authority’s expectations, ways of working etc to appropriately direct company strategy. Share updates with colleagues.
- Work with authorities if company position differs from authority position in order to obtain a better outcome for the business/patients as appropriate
- Populate and Maintain Regulatory Databases. Responsible for database entry and the document management of regulatory transactions undertaken at local level
- Participate in ad hoc and routine QC checking of regulatory data bases
- Obtain Authority Approvals for Supply of Unlicensed Medicines (Named Patient/Compassionate Use)
- Following a request from a prescriber and corporate approval, obtain necessary approvals to import and supply unlicensed medicines to address unmet patient needs
- Product Discontinuations: Liaise with internal and external client team/commercial/medical functions and advise on regulatory action required for discontinuation of a product in the country marketplace
- Ensure implementation of Good Regulatory Practice (appropriate for all tasks)
- Adhere to relevant procedures and practices to ensure GRP is maintained
- Life sciences or chemistry graduate to honours level or equivalent
- Master’s degree, Post Graduate Diploma or PhD preferred
- Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory Affairs)
- Previous experience in Regulatory Affairs (Guidance note 14 Medicines The supply of unlicensed medicinal Products)
- Member of The Organisation for Professionals in Regulatory Affairs (TOPRA) preferred
- Knowledge of the global unlicensed medicines market and or the Pharmaceutical industry is preferred
- Excellent communication skills with internal and external partners
- Analytical thinking
- Ability to prioritise effectively
- Results focused with attention to detail
- Ability to multitask
- Excellent written and verbal communication skills
- Able to work on own and make decisions independently, where needed
- Reports to Global Director Medicines Access
- Ability to work under own initiative and in a team
- Overtime may be required from time to time
- There will be travel to Germany and the US offices
BAP offers a competitive salary and bonus plan.