Regulatory Affairs Senior Manager

This role will support one or more products from a regional regulatory perspective. As a member of the Regulatory Affairs team, you will achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions.

The purpose of this role is:

- To ensure that all the required licenses in order to support clinical trials for investigational medicinal products as well as to market approved medicinal products are obtained and maintained
- To ensure timely regulatory compliance with above approvals
- As requested this role may provide management and leadership by supervising one or more other regional regulatory leads and/or support staff

This role is responsible for:

- Advising the team on regional considerations in developing strategy
- Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
- May manage one or more regional leads or support roles

Strategy and Execution:

- Plans and manages regulatory submissions (eg clinical trial and marketing applications) for products within the 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 team strategy
- Provides regulatory direction on regional regulatory mechanisms to optimize product development (eg expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and pediatric plan)
- Directs the development of the regional product label by collaborating with the Labelling 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 team strategy, advise development team on regulatory implications and requirements related to global clinical development plans and objectives
- Co-ordinates company responses to requests from regulatory authorities, eg 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 Regulatory Affairs department and line Management

- Develop predictions for expectations and risks associated with outcomes by regulatory agencies

Ensure regulatory product compliance for product (eg IMR, PMCs, paediatric and other agency commitments)

Collaboration:

- Share regulatory information and implications with colleagues on an ongoing basis and provide advice on regional considerations
- Communicate and ensure alignment of regional management before wider 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 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, guidance's, current regulatory environment and competitor labelling

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 relevant Sr. management
- Manages core regulatory activities to ensure effective regional agency interactions consistent with the regulatory strategy-includes contingency regulatory planning/risk assessment

Management:

- 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 regional legislation
- Working with policies, procedures and SOPs
- Experience with national legislation and regulations relating to medicinal products
- Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals.
- Understanding of drug development

Scientific/Technical Excellence:

- 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.

This role offers a very competitive rate of pay and will look great on anyone's CV!

Please get in touch with Matt 

Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice. By submitting personal data to any company or division within the Allegis Group, the applicant is providing explicit consent to the use of such data by the Allegis Group and to the transfer of such data to and from the Allegis Group companies within the UK, Europe and outside the European Economic Area in connection with the fulfilment of the applicant's voluntary requests, and the fulfilment of other job opportunities that match the applicant's profile, and confirms that they may be contacted about such job opportunities.