Job Information
J&J Family of Companies Senior Regulatory Project Manager in England, United Kingdom
Senior Regulatory Project Manager - 2406213095W
Description
Janssen is recruiting for a UK Senior Regulatory Project Manager, located in High Wycombe.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
In this role, you will take ownership for a number of actively developing products. Build regulatory strategy for developing products with Regulatory Manager, local and regional teams.
Key Responsibilities:
Provide Regulatory leadership for a portfolio of promoted and non-promoted products
Oversee preparation and submission of regulatory documentation.
Monitors deadlines for different projects to ensure they are met or escalated to a Senior Regulatory manager and/or Head of RA.
Responsible for the content of the local labelling documents released to prescribers and patients.
Prepares and distributes local labelling documents within stipulated timelines following receipt of relevant approvals.
Prepares for and manages local procedures assuring timely execution and compliance
Provide RA expertise to local brand team.
Co-ordinates cross functional team to implement/update Risk Management Plans and Risk Management Educational Material.
Compliance
Complete above activities to ensure compliance with all regulatory requirements.
Develops and maintain in depth knowledge of regulations/legislation.
Supports EMEA with collection of RA competitive intelligence as required.
Internal contacts
- 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
Support and contribute to GRA-EMEA initiatives as requested by Head of RA.
Contribute to initiatives around lessons learnt and change management to ensure efficiency gains.
Actively contribute to increasing the regulatory expertise of the team by mentoring of junior regulatory colleagues
Qualifications
Qualifications
Education:
- University Degree in Pharmacy, Biology, Chemistry or related Life Science
Experience and Skills:
Required:
Regulatory Affairs experience at operational level.
Direct experience and strong knowledge of general EU and UK regulatory requirements and guidelines.
Strong data gathering and analytical skills are essential.
Strong leadership, persuading/ influencing, negotiating skills are required.
Other:
Advanced English Language
Limited travel.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
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!
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Primary Location Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization Janssen Cilag Ltd. (7360)
Job Function Regulatory Affairs
Req ID: 2406213095W