Purpose of role
Responsible for providing regulatory strategy and regulatory oversight and leadership within the asset team and regulatory and pharmacovigilance (sub) teams.
Drives optimal regulatory outcomes for the portfolio assets assigned across development and life cycle management.
Key Responsibilities – Strategic, Financial, Resource, Management, Decision Rights, Key interactions (Internally / Externally)
- Develop and lead regulatory strategies and drive the execution of registration plans for development, regulatory approval and optimal regulatory data protection/market exclusivity (RDP/ME) and market access of Mundipharma early and late stage development assets in the assigned regions.
- Provide regulatory advice and expertise to R&D, commercial asset teams, business development, alliance partners and other activities related to innovating, developing and enhancing the value of Mundipharma’s pipeline.
- Provide specialist advice and expertise in specific technical regulatory areas CMC, labelling or LCM to support regulatory strategy and execution.
Tasks that individual will carry out
- Provide regulatory expertise for the development asset portfolio utilising optimised regulatory pathways and submission routes to achieve strong commercially focussed labels and expeditious approvals that maximise RDP/ME.
- Defining regulatory pathways and strategic options, ensuring alignment and driving regulatory recommendations within the asset team and other parts of the business, as part of an integrated drug development plan for pre-IND through to MAA assets in key territories, including development of new indications.
- Lead the development, documentation and review of the Strategic Regulatory Plan for the assigned assets including assessment of the probability of regulatory success together with risk mitigation measures; utilise available resources including outsourcing partners to efficiently deliver regulatory milestones in accordance with the plan
- Maintain ownership and accountability for timely and effective Regulatory Agency negotiations and interactions throughout the asset development and registration process.
- Drive regulatory outcomes and local delivery in the Independent associated Companies (IACs) in line with development & commercial goals through optimal partnership with IACs
- Responsible for regulatory representation in Alliance Management with Partner Companies for their assigned assets
- Provision of strategic direction and oversight of delivery output from outsourcing partners to ensure alignment with regulatory strategies, effective execution and quality submissions and regulatory agency interactions.
- Provision of strong regulatory expertise into assigned Due Diligence for new assets, ensuring a solution based focus to give key regulatory considerations and regulatory direction for business development.
- Provide expertise in particular regulatory focused disciplines (CMC, labelling, LCM) to support early and late stage and life cycle management assets in development.
Key Skills required to do the role
- Extensive regulatory experience in the biotech/pharmaceutical industry with a broad, in-depth knowledge and experience of drug development.
- A track record of overseeing a substantial number and quality of drug development regulatory submissions and approvals, including Clinical Trial Applications (CTAs) and Investigational New Drug (IND) applications, and Marketing Authorisation Applications (MAAs) and New Drug Applications (NDAs). working with or from within health authorities.
- Knowledge, experience and track record of delivering successful regulatory outcomes for new products across various territories including US, EU, Asia working with diverse Regulatory Authorities such as EMA, FDA, BfArM, MHRA, TGA, PMDA etc.
- Fully conversant with strategic development/regulatory considerations and opportunities for accelerated approval, conditional approval and other regulatory processes for expediting access in the above-mentioned territories.
- A strong strategic regulatory mind-set and demonstrated ability in leading company interactions with various regulatory health authorities across diverse issues in diplomatic and persuasive ways
- Excellent collaborator, ability to build relationships and inspire confidence and respect at all levels; strong stakeholder and customer focus
- Outstanding communication skills; ability to build rapport and demonstrate strong influencing and negotiation skills; excellent listening ability – receptive to feedback and demonstrates flexibility, curiosity and an ability to learn.
- Ability to work effectively within a flexible resourcing environment harnessing both internal and external (outsourcing) providers to deliver regulatory results.