Global Regulatory Strategy Project Lead

4 weeks ago

Kingston upon Hull, United Kingdom Indivior Full time

TITLE:
Global Regulatory Strategy Project Lead

Title: Global Regulatory Strategy Project Lead

Reports To: Head of Global Regulatory Strategy

Location: UK

The Global Regulatory Project Lead (GRL) is the regulatory lead for the creation of regulatory strategies for AMSF / DMF, pipeline projects from preclinical to Phases I, II and III; supporting existing product development with regulatory implementation plans to meet business needs and manage all aspects of product throughout its life cycle, and where needed support budgeting activities. The GRL may matrix manage regulatory people at the project level to facilitate projects through the development process, manage post approval changes and all other related activities to ensure products are maintained and remain compliant with approved registered details throughout their life cycle, globally.

In this role, the GRL is seasoned in providing regulatory guidance and regulatory strategy, at all phases of research and development to create the regulatory pathway for regulatory approval that optimises a drug products global potential and labelling claims. The GRL should have a substantial understanding of pre-clinical requirements, CMC process inc AMSF / DMF, and Phase I-III clinical trials and be able to support launch and maintenance of products post approval, including CMC and Labelling. They should be able to interact with all internal functional groups and exhibit the ability to provide guidance related to the compilation of global regulatory dossiers in eCTD format and liaise with project manager at the health authority to resolve any potential issues. They should also have good supervisory skills and the ability to assist with personal development.

PRIMARY RESPONSIBILITIES:

- As the GRL, develop excellent relationships and work with Senior Management, Area/Regional Regulatory, Clinical, Scientific, Supply and QA, Medical, Marketing, and Finance colleagues to develop strategic plans and risk assessments for developmental efforts in support of individual assigned projects that will ensure the timely entry of new products to the market.
- Ensure global DMFs and dossiers are prepared for regulatory submissions, and where appropriate, updated to comply with any feedback for local requirements and / or feedback from local agencies following consultation. Post approval, the dossiers should be maintained throughout the life cycle of the products by working closely with Supply, QA and CMOs.
- Provide regulatory expertise to individuals assigned to global product development and regulatory teams, where appropriate seeking input from the regional regulatory colleagues to develop global regulatory strategies. This includes the strategic review of the submission documents, provide strategic as well as high quality input to Response to Questions (RTQs) from the agencies.
- Ensure that new ASMF / DMFS, new products, new dosage forms, and new indications for individually assigned projects are registered in a timely fashion. Ensure completion of all regulatory related post approval activities to support launch of products and lifecycle management.
- Provide planning and leadership to the Regulatory department by ensuring that appropriate structures, systems, competencies, budgets and values are developed, for early stage drug product development as well as post approval and life cycle management.
- Draft, review and administer regulatory strategy, plans and policy throughout the development process for individually assigned projects, by effective collaboration with internal stakeholders
- Actively liaise with regulatory authorities by leading meetings, managing correspondence, and providing follow-through for individually assigned projects. Negotiate with regulatory authorities for efficient and timely product review and approval for individually assigned projects. Lead internal Indivior colleagues in follow-through on regulatory commitments for individually assigned projects.
- Where required, establish ongoing liaison with key opinion leaders and government officials and ensure that significant developments in the field are identified and monitored.
- Ensure that the interfaces between Regulatory and other departments are managed optimally for individually assigned projects. Provide effective team communication throughout the Regulatory department with suitable reporting systems, structures, and appropriate training for individually assigned projects.
- Ensure and champion all compliance related activities associated with their project(s) including any change controls, storing and updating reg correspondence and other documentation in RIMS.
- Make positive contribution to the regulatory function, work with flexibility to meet strategic objectives, including and not limited to, supporting ad-hoc regional activities, provide coaching to other regulatory team members in various aspects of regulatory expertise, (, budgets, resource allocation).

QUALIFICATIONS:

- 1.Bac

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