Regulatory Manager

Senior Regulatory Manager

Location: High Wycombe (Hybrid working)

Duration: 12 months

Hours: 37.5

Imagine your next project focusing on the development or proposal of a local regulatory strategy aligned with relevant regulatory standards. Your role entails overseeing regulatory activities within a specific therapeutic area, encompassing tasks such as managing agency submissions and inquiries, participating in brand team (CVT) meetings as necessary, and orchestrating regulatory processes to uphold compliance with regulations and foster an inspection-ready environment.

roles and responsibilities

Provide Regulatory management and implementation for a portfolio of development and promoted products

This will involve: 

• Partner with RA Head and allocated CVT to provide RA strategic and technical expertise and support for submissions and HA interactions.

• Prepare and submit new UK National or Reliance MAA, ILAP IP, TDP, UK PIPs, and other local submissions as assigned.

• Review and approve regulatory variation documentation prepared and submitted by the Regional Regulatory Management Centre within given timelines to ensure they are met.

• Responsible for the content, preparation, and distribution of the local labelling documents released to prescribers and patients.

• Prepares for and leads local procedures following the EMEA Regulatory Affairs strategic plan, assuring timely execution and compliance with all regulatory requirements.

• Implements Risk Management Plans and Risk Minimisation Materials.

• Develops and maintains in-depth knowledge of regulations/legislation.

• Supports local and regional teams with the collection of RA competitive intelligence as required.

• Undertake and support internal initiatives as requested by the Head of RA.

• Mentor other team members

• Leads the adoption and implementation of new systems and processes to streamline routine regulatory activities.

• Collaborates with, and influences cross-functional colleagues to ensure efficiency gains and to support business continuity

• Develops and maintains in depth knowledge of regulations/legislation

• Be up-to-date with and adapt early to local changes in the regulatory environment

• Supports EMEA and local business with collection of RA competitive intelligence as required

Internal contacts

• Proactively shares key regulatory insights with CVT and regional RA to help craft brand strategy!

• Support other departments based on their needs (e.g. Supply Chain, Quality, Medical, and Commercial) by providing documentation and information in response to requests.

External contacts

• Contact local Health Authorities to resolve general queries (some product specific) when these cannot be addressed internally ensuring a positive interaction in any communication.

Miscellaneous

• Actively grow the regulatory expertise of the team by mentoring junior regulatory colleagues.

how to succeed

As a regulatory manager, you are expected to possess 5 to 10 years of experience operating at both operational and strategic levels within the pharmaceutical sector. You should demonstrate direct experience and a comprehensive understanding of the regulatory landscape in both the UK and EU.

You will also bring:

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

• Submission experience 

• Strong data gathering and analytical skills as well as strategic skills are critical.

Benefits

This role offers a very competitive hourly rate. This contract is scheduled to last for a duration of 12 months, with a potential review for an extension and the opportunity for conversion into a permanent position.

you are welcome here

Johnson & Johnson is 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.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson. 

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE & Umbrella options are available. 

Diversity, Equity & Inclusion

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 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”.