Regional Regulatory Lead, Senior Manager - United Kingdom
- This role will support one or more products from a regional regulatory perspective.
- As a member of the Global Regulatory Team (GRT), they will achieve the desired labeling by developing and executing regional regulatory strategies and managing effective agency interactions.
- To ensure that our company acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products
- To ensure regulatory compliance, with a focus on patient safety
- As requested this role may provide management and leadership by supervising one or more other regional regulatory leads and/or support staff (dependent on grade)
- This role is accountable for:
- Executing the approved regional strategy for assigned programs
- Representing the region
- This role is responsible for:
- Advising the GRT on regional considerations in developing strategy
- Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
- Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within company's portfolio in compliance with global filing plans and local regulatory requirements.
- Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Leads development of regional regulatory documents and meetings in accordance with GRT strategy
- Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plan)
- Directs the development of the regional product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
- Manages regional label negotiation activities
- With minimal supervision, participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
- Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives
- Obtains and maintains Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs)
- Communicates regulatory strategies as appropriate such that expectations are understood.
- Estimate the likelihood of regulatory success based on proposed strategies and discuss with GRT and line Management
- Develop predictions for expectations and risks associated with outcomes by regulatory agencies
- Ensure regulatory product compliance for product (e.g. IMR, PMCs, pediatric and other agency commitments)
- Share regulatory information and implications with the GRT colleagues on an ongoing basis and provide advice on regional considerations
- Communicate and ensure alignment of regional management before GRT strategy decisions
- Partner with regional management and peers to ensure consistency in procedures and agency interactions
- Regulatory Research
- Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to company products.
- Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
- Evaluates and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labeling
- Health Authority Interactions
- Act as contact and create relationships with agency staff on specific product assignment
- Document and communicate details and outcomes of regulatory agency interactions to GRT and relevant sr. management
- Manages core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy—includes contingency regulatory planning/risk assessment
Region Specific Activities
- US: Advises and supports promotion group regarding applicability of data for product communication in the US
- EU: Review and approve promotional and non-promotional materials for use in international region
- APAC, LACAN, EEMEA: Lead the product lifecycle for individual countries per national agency requirements
- APAC, LACAN, EEMEA: Work through the regional leads to manage distributor markets
- Supports communication/collaboration between direct reports who are regional leads and regional head for program issues requiring next level engagement
- Provides managerial leadership & direction to assigned team allowing appropriate prioritization of resources to achieve goals.
Knowledge and Skills:
- Regulatory knowledge in national regulations
- Working with policies, procedures and SOP’s
- Experience with national legislation and regulations relating to medicinal products
- Understanding of the registration procedures in region for MA, post approval changes, extensions and renewals.
- Understanding of drug development
Scientific / Technical Excellence:
- Team work
- Negotiation skills
- Good communication skills - both oral and written
- Ability to understand and communicate scientific/clinical information
- Ability to anticipate and prevent potential issues
- Communication of regulatory strategies such that expectations are understood.
- Anticipate regulatory agency responses to strategy
- Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage
- Comprehensive understanding of regulatory activities, touch points and how they affect projects and processes
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
- Cultural awareness and sensitivity to achieve results across both regional country and International borders.