J&J Family of Companies Regulatory Executive (1/2) in High Wycombe, United Kingdom
Location : High Wycombe, UK
Management of the regulatory activities in line with the existing processes to ensure compliance with regulatory requirements and an inspection ready culture This includes:
Responsible for specific therapeutic area activities, including but not limited to handling the Agency submissions and questions, including CVT attendance as required
Cross portfolio technical and administrative activities as required
Contribute to shaping local regulatory strategy in line with the applicable Regulatory requirements.
Provide Regulatory support for a portfolio of promoted and non-promoted products
Prepares and submits regulatory documentation as required
Monitors deadlines for different projects to ensure they are met or escalated to a
Regulatory Affairs manager and/or Head of RA.
- Responsible for the content of the local labelling documents released to prescribers and
- Prepares and distributes local labelling documents within stipulated timelines following
receipt of relevant approvals
- Prepares for and manages local procedures following the EMEA Regulatory Affairs
strategic plan, assuring timely execution and compliance
Partner with allocated CVT to provide RA expertise and support
Implements Risk Management Plans and when required co-ordinates a cross-functional team to implement/update Risk Management Educational Material.
Deputises for Regulatory Affairs Manager when required
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.
SME on given topic and author of relevant SOPs
Support other departments based on their needs (e.g. Supply Chain, Quality, Medical, and Commercial) by providing documentation and information in response to requests.
Proactively shares key regulatory insights with CVT help shape brand strategy
- Contact local Health Authorities to resolve general queries (some product specific) when these cannot be addressed internally ensuring a positive interaction in any
Undertake, support and contribute to LOC RA-GRA-EMEA initiatives as requested by Head of RA.
Contribute to initiatives around lessons learnt and change management to ensure
- Actively contribute to increasing the regulatory expertise of the team by mentoring of
junior regulatory colleagues
University Degree in Pharmacy, Biology, Chemistry or related Life Science
Regulatory Affairs experience at operational and strategic level.
Direct experience and strong knowledge of general regulatory requirements and guidelines.
Strong data gathering and analytical skills are essential.
Strong persuading/ influencing, negotiating skills are required.
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.
United Kingdom-England-High Wycombe-
Janssen Cilag Ltd. (7360)
J&J Family of Companies
- J&J Family of Companies Jobs