International Regulatory Manager 100%
Within the Emerging and Regional Affiliates Support Team, you will be responsible for leading regulatory activities for specific International markets and actively contributing to the development and implementation of regulatory strategies for assigned products across the International affiliates. You are a key member of the global product team(s), and the primary contact for affiliates to develop and execute regulatory strategies.
Key activities/responsibilities include:
- Provide expert knowledge on regulatory requirements and environment for assigned International countries
- Be a strong partner to affiliates and the global product teams, finding innovative solutions and challenging the status quo
- Liaise with global teams to ensure clinical development requirements in International countries are integrated into the global development plans
- Accountable for clinical trial application strategy and support to Clinical Trial Regulatory Management group for dossier dispatch
- Collaborate with global and local stakeholders (e.g. affiliate DRAs, Labelling Managers and International Technical Partner) to generate and deliver the product strategy, ensuring timely submission of regulatory applications (initial licenses, new indications & lifecycle management)
- Advocate and champion DRA affiliates within the global organisation, ensuring that the affiliate voice is represented within headquarters
- Lead planning of Health Authority Meetings
- Lead response to Health Authority questions and provide authoring support as needed
- Actively participate in the RAFT (Regulatory Affairs Functional Team) partnering with the Global Regulatory Leader and EU and US Partners to discuss and align on regulatory activities
- In collaboration with PTR International Operations, develop and execute objectives and plans towards aligning one global regulatory voice/outlook to International affiliates
- Participate in projects and initiatives outside of the core scope of International Regulatory Manager responsibilities
- Travel as needed
- University Degree, preferably in a scientific discipline.
- Minimum 5 years of experience in International Drug Regulatory Affairs
- Knowledge and experience of global regulatory processes
- Good practical experience of contacts with health authorities
- Basic working knowledge of core processes in discovery, development, manufacturing and marketing.
- Fluency in written and spoken English, German oral
- Teamwork: ability to influence and work both independently and collaboratively in a team structure
- Strategic agility: ability to develop clear, effective and creative regulatory strategies to support goals
- Communication and influencing: ability to effectively negotiate with individuals or groups on more than one level who may have different interests or goals to reach consensus and achieve team objectives
- Stakeholder Management: can effectively partner with others to understand and provide best solutions. Takes own initiative to address problems or opportunities and easily connects with appropriate stakeholder to find best solution.
- Regulatory knowledge: possess good understanding of complexities and challenges in a global regulatory environment.