Senior Manager, Regulatory Affairs, Oncology - United Kingdom
- 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. Effectively communicates objective assessments of the likelihood of success of these regulatory strategies.
- Provides a regulatory expertise and strategic focus for assigned development projects and /or marketed product life cycle management.
- As Regional Lead, may be called upon to act as deputy to the Global Regulatory lead, attending internal 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.
- Primary 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 for own region and represents region as needed at project team and ensures 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 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 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 delegates to vendor with oversight.
- Usually includes some oversight of vendor activities.
- Leads and manages meetings in own region (e.g. EMA for Europe) and have awareness of relevant regulatory agency meetings scheduled with other regions or Local company affiliates for project(s)/product(s) of responsibility.
- May be called upon to support in due diligence for licensing opportunities, development and /or marketed product opportunities.
- Builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to support company strategic goals and objectives.
- Identifies regulatory requirements across area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and /or Region in these areas.
- 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.
- Sound working knowledge of regulations and guidances governing drugs and biologics in development, including post-marketing in the US and/or EU (relevant to role). A good understanding of basic regulatory requirements in emerging markets is a plus.
- Understands and interprets complex scientific issues and capability to relate to regulatory requirements and strategy.
- Proven regulatory submissions capability in a region (Europe, US, EM).
- 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.
- Able to demonstrate skill(s) 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.
- Effective manager who is able to bring working teams together for common objectives.
- Experience managing relationships with CROs and/or contractors preferred.