Senior Regulatory Affairs Manager

Location: High Wycombe

Duration: 12 month fixed term contract

Hours: 37 hours per week

Pay rate range: Competitive hourly rate

Working mode: Hybrid (3 days on-site, 2 working from home)

OUTSIDE IR35

Imagine your next project being responsible for specific therapeutic area regulatory activities, including but not limited to handling the Agency submissions and questions, including attendance of brand team (CVT) as required and management of the regulatory activities in line with the existing processes to ensure compliance with regulatory requirements and an inspection-ready culture. Janssen is currently recruiting for a UK Senior Regulatory Manager, located in High Wycombe.

roles and responsibilities

• Develop or propose a local regulatory strategy in accordance with the applicable regulatory requirements.

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

• 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.

• Coaches 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.

how to succeed

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

• Regulatory Affairs experience at the operational and strategic levels (approx. 10 years of experience).

• Direct experience and solid understanding of the regulatory environment within the UK and EU. Ideally post Brexit 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 will run for 12 months and has a strong chance of extension. 

you are welcome here

Janssen 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 Janssen

Janssen is the Pharmaceutical Companies of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare Company. At Janssen, we bring together top scientists and researchers to pursue the most promising science and drive collaboration to create visionary medicines and healthcare solutions covering five priority therapeutic areas - Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience and Oncology. Contribute to the next pharmaceutical breakthrough with your next project at Janssen. 

Janssen UK: https://www.janssen.com/uk/

Janssen Ireland: https://www.janssen.com/ireland/

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, LTD & Umbrella options are available. 

questions

If you would like some additional information about the role please contact:  sara.marsalo@randstadsourceright.co.uk

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”.