Purpose of role
Responsible for providing global regulatory strategy and leadership within the development asset teams including but not limited to the oncology therapeutic area, and leading global regulatory sub teams.
Drives optimal regulatory outcomes for the development assets across development and life cycle management to deliver technical excellence enabling R&D and commercial success.
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 and regulatory approval of new assets, working closely with other technical functions across the Mundipharma organisation.
- Provide regulatory advice and expertise to R&D, commercial asset teams, business development, alliance partners and other activities related to developing and maintaining Mundipharma’s pipeline.
Tasks that individual will carry out:
- Provide regulatory expertise for the development asset portfolio utilising optimised regulatory pathways and submissions to achieve expedited and commercially competitive approvals of assets.
- Defining regulatory pathways and strategic options for asset expansion globally, ensuring alignment with the Independent associated Companies (IACs) business cases and commercial planning.
- Maintain ownership and accountability for timely and effective Regulatory Agency negotiations and interactions throughout the internal asset development, registration and maintenance process.
- 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, particulally in oncology, into assigned Due Diligence for new assets.
Key Skills /Experience required to do the role:
- Extensive regulatory experience in development and registration of new products globally with demonstrable oncology therapeutic area experience.
- 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 (BLAs). working with or from within health authorities.
- Knowledge, experience and track record of delivering successful regulatory outcomes for development products across various territories including US, EU, Asia working with diverse Regulatory Authorities such as EMA, FDA, TGA, PMDA etc.
- 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.