Associate Director, Regulatory Affairs - United Kingdom
- 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 lifecycle 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.
Education, Skills, & Experience
- 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