Regulatory Project Manager
Hybrid working
Are you an experienced Regulatory professional with expertise in regulatory management/ strategy?
Would you like to work for a world leading biopharmaceutical company, managing a portfolio of products and clinical assets?
My client promotes R&D and advanced technologies to make innovative biopharmaceutical products to prevent and treat disease. Due to their continued growth and expanding portfolio of products, they are looking for an experienced regulatory professional to manage a portfolio of products across the product lifecycle and to be the primary interface with the local regulatory authorities.
The Regulatory Project Manager will proactively lead the defining and implementing of effective regulatory strategy, influencing as needed to reflect business needs. Other key responsibilities will include:
- Being responsible for the regulatory management (delivery and maintenance) of clinical assets and MAs for a portfolio of products for US
- Ensuring product information is compliant with MA.
- Ensuring that product Summary of Product Characteristics (SPCs) and Patient Information Leaflets (PILs)/ labelling are compliant with MA and with regulatory requirements
- Co-ordinating national input into responses to regulatory questions and regulatory commitments, ensuring these are in alignment with regulatory requirements and agreed strategy and timelines.
- Being responsible for the local management of product registration documents in regulatory databases and repositories.
- Managing regulatory agency correspondence in accordance with company procedures
- Notifying Regulatory agencies about product quality and safety issues in an expeditious manner in accordance with company procedures
- Completing Marketing Authorisation Holder (MAH) reviews of Periodic Quality Reviews for all registered products in responsible portfolio
- Effectively planning regulatory activities
- Providing considered regulatory advice, leadership, and expertise to brand teams and to other regulatory and cross functional groups.
- Co-ordinating meetings with regulatory authorities and plays a key role in these interactions
As Regulatory Project Lead, you share the team values which include integrity, collaboration, diversity of thinking and respect.
To be considered for the Regulatory Project Lead role you will need the following skills and experience:
- In depth understanding and practical experience of national regulations, guidelines and working practices and of the regulatory issues relevant to a portfolio.
- Knowledge of the commercial and medical issues pertaining to the assigned portfolio, including an awareness of competitor products and activities
- An understanding of the impact of the regulatory environment and proposed changes which are likely to impact the business in the medium term.
- Can define regulatory strategy
- An in depth understanding of regulatory governance, medical and safety
- Must be eligible to work in the US