Job Description - Senior Regulatory Project Manager (2506239232W)
Senior Regulatory Project Manager - 2506239232W
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.
* Monitor 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.
* Prepare and distribute local labelling documents within stipulated timelines following receipt of relevant approvals.
* Prepare for and manage local procedures assuring timely execution and compliance.
* Provide RA expertise to local brand team.
* Coordinate 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.
* Develop and maintain in-depth knowledge of regulations/legislation.
* Support 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.
* 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 junior regulatory colleagues.
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.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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