Senior Regulatory Project Manager
Veröffentlicht:
16 September 2024Pensum:
100%Vertrag:
Festanstellung- Arbeitsort:Johnson
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
Kontakt
Synthes GmbH