Regulatory Affairs Manager - United Kingdom

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

Janssen is recruiting for a UK Regulatory Manager, located in High Wycombe. We work in a hybrid environment in order to keep a healthy work-life balance.

In this role, we offer you a people management opportunity combined with strategic leadership in a highly dynamic environment. You will drive the regulatory strategy for our exciting developing pipeline to serve our UK patients.

Key Responsibilities:

Provide regulatory leadership for a portfolio of promoted products

• Partner with local and global teams to provide regulatory strategic and technical expertise for submissions, HA interactions, and brand strategy.
• Coordinates and submits new MAA, ILAP IP, TDP, and UK PIPs and other local submissions as assigned.
• Lead preparation for and discussion in health authority meetings for local activities.
• Accountable for the content of the local labeling documents released to prescribers and patients.
• Supports regional and local businesses with the collection of RA competitive intelligence as required.
• Build positive relationships with Health Authority colleagues to enable product strategies.

Departmental management

• Mentor or line-manage team members, driving performance through enablement.
• Owns the adoption and implementation of new systems and processes to streamline routine regulatory activities.

Compliance

• Ensures compliance excellence with all regulatory requirements for self and team
• Develops and maintains in-depth knowledge of regulations/legislation
• Be up-to-date with and adapt early to local changes in the regulatory environment.

Qualifications

Education:

• University Degree in Pharmacy, Biology, Chemistry, or related Life Science