Associate Director, Regulatory Affairs, Marketed Products (EU) - United Kingdom
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- Collaborates to define, develop and lead global and/or regional strategies to maximize regulatory success towards achievement of program objectives. Effectively communicates objective assessments of the likelihood of success of these regulatory strategies.
- Provides strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs and/or oversight of marketed product support, while maintaining full compliance with applicable regulatory requirements.
- Provide regulatory expertise for multiple projects or one complex development project and / or marketed product(s) of responsibility.
- Manages and trains direct reports and / or mentors team members, if required, to support scope of project work.
- May be called upon to act as deputy to the Global Regulatory Lead, therapeutic area head and/ or Region regulatory head, and/or Marketed Products Head, attending internal leadership team meetings, as appropriate.
- Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to project areas and/ or region of responsibility enabling proactive approach and planning to future business requirements.
- Primary EMA contact with health authorities for project(s)/products of responsibility in regions of responsibility, or can delegate to staff and/or vendor with oversight. Informs the business.
- Leads the regulatory working team globally or for own region and represents as needed at project team and ensures global and/or regional regulatory life-cycle management strategy and submission planning written and executed according to plan – or oversees if delegated to staff and/ or vendor.
- For the project(s)/product(s) of responsibility, collaborates with Global and Regional colleagues for the authoring of global regulatory strategies and ensures own critical deliverables as agreed within the global regulatory strategy and planning.
- Where responsibility includes a marketed product, provides oversight to ensure regulatory compliance, including oversight of the product related data in the registration database.
- Accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within region (s) of responsibility (E.g. EMA submissions for Europe).
- Identifies relevant global /regional regulatory requirements and provides regulatory guidance, and expertise to internal team on the assigned project(s) of responsibility. Authors and reviews global and/ or regional regulatory strategies as well as executes day-to-day activities for projects or may delegates to staff and / or vendor with oversight.
- Usually includes supervision of one or more direct reports and / or vendor activities.
- Leads and manages meetings and / or interactions with regulatory authorities and agency meetings; or delegates and oversees direct reports and / or vendor; negotiates on behalf of project team as necessary.
- Regulatory reviewer in due diligence for licensing opportunities, development and /or marketed product opportunities.
- Proactively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to achieve company strategic goals and objectives.
- Identifies regulatory requirements and trends across area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas, as requested.
- Identifies and proposes solutions to the management of resource gaps for areas of responsibility.
- Presents to senior management as requested.
- BSc degree or equivalent in science; advanced degree preferred.
- Considerable pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and /or post-marketing phases.
- Solid working knowledge of regulations and guidances governing drugs and biologics in all phases of development, including post-marketing, in the US and/or EU (relevant to role). A good understanding of basic regulatory requirements in emerging markets preferred.
- Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
- Preferred experience in managing major regulatory filing(s); and significant contributor to regulatory and/or development strategies.
- Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Generally strong and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
- Generally strong in working well with others and within global teams; and acceptable at communicating with senior leadership.
- Generally strong leader who is effective manager and is able to bring working teams together for common objectives. Able to mentor and develop skills of team members.
- Experience in managing personnel a plus; experience managing relationships with CROs and/or contractors also preferred.