Regulatory Director - EU - Netherlands
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- The new regulatory Director is a recognized/developing expert on the current Regulatory environment.
- Leads and/or manages a group of Regulatory professionals responsible for delivery in a specific region to contribute to the global drug project team's deliverables.
- Develops and shapes the strategic direction of the group, leading and implementing change projects for improved processes and performance.
- Participates in the recruitment and development of staff and in talent and performance management activities for the group.
- Oversees operational delivery and efficiency and ensures appropriate resource planning.
- Supports staff assignment to support drug projects and business improvement projects.
- Establishes and develops external relationships with key Regulatory stakeholders, leveraging these to maintain competitive advantage.
Tasks and responsibilities
- As assigned, accountable for the development and implementation of the global or regional regulatory strategy for a product/ group of products, and for ensuring that the strategy is designed to deliver a rapid, quality approval with advantageous labelling in keeping with the properties of the product(s) and the needs identified by the business, and patients
- Accountable for product maintenance, supply and compliance activities associated with marketed brands, where applicable
- Delivers all regulatory milestones including assessment of the approvability of the program together with risk mitigation measures
- Leads the objective assessment of emerging internal and external data against aspirations and update senior management on project risks/mitigation activities
- Works collaboratively with the global/regional/local regulatory affairs staff at Acerta and AstraZeneca, to influence developing views/guidance within leading Health Authorities on specific topics of relevance to their project or regulatory more generally. Ensures effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements
- As appropriate and as assigned, participates/leads joint regulatory and/or cross-functional team meetings
- Leads regulatory staff working on a product/project to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality
- Participates in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project
- Leads the review of key submission documents and identify any potential risks along with possible contingencies to ensure the earliest appropriate submission and earliest possible approval of key deliverables with advantageous labelling
- Creates, communicates and updates the Regulatory Strategy Document for assigned products/projects.
- Ensures appropriate consultation and Peer Review. Defines the regulatory development plan and own the planning and construction of the global dossier and core prescribing information
- Provides regulatory leadership as needed in product license-in/due diligence review, product divestment and product withdrawal
- Ensures excellent understanding of the commercial/business goals to contribute as an equal partner with medical and commercial colleagues in cross functional delivery of business objectives
- Participates in routine and ad hoc departmental meetings and other business reviews or meetings to develop and maintain a strong awareness of the evolving internal and external regulatory needs and requirements, and of the hematology business environment
- Expected to share best practices within the department and cross-functionally, identify and communicate opportunities for departmental enhancements and efficiencies
- Participates in and/or otherwise supports development and implementation of new or updated Regulatory systems, processes, Standard Operating Procedures (SOPs) or other relevant tools
- As relevant, provides day-to-day guidance and direction to less experienced Regulatory staff and their work supporting the same projects or other assignments
- Consistently complies with all governing laws, regulations, Acerta Pharma SOPs and other guidelines
Competencies & experience
- Substantial direct experience of working at the Regulatory Authority interface and leading delivery of regulatory projects through key milestones and investment decisions
- Has lead cross functional teams through key milestones meeting(s) with Health Authorities (preferably FDA), including management/delivery of the interaction
- Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company, CMC, SMG, etc., or experience at a health authority
- Proven leadership and program management experience
- Has assumed a leadership role in a recent, successful major Regulatory submission to FDA and/or EMA/CHMP, such as sNDA/sBLA, NDA/BLA
- Consistently demonstrating an ability to think strategically and critically evaluate risks to regulatory activities, taking account of external trends in both regulatory and business environment
- True team player, within and outside of Regulatory Affairs
- Recent experience with initial NDA/BLA filing, with the FDA or MAA with EMA/CHMP
- Strategic Influencing – through well thought out rationale and effective communication skills, able to influence key decisions
- Ability to gain commitment – effectively uses interpersonal abilities to build relationships and gain acceptance of ideas
- Builds effective partnerships – identified opportunities and takes actions to build effective relationships within team and with other areas
- Leadership – effectively role models the culture & values and expertly guides the team to its common mission.
- Coach and mentor to others – sought out to mentor others and identifies as well as develops regulatory talent, with commitment to learning and personal development.
- The ability to work in a complex, business critical and high profile environment building credibility in ambiguous situations
- Courage in communicating regulatory decisions and/or risks which will be met with resistance by key stakeholder