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J&J Family of Companies Regulatory Executive (1/2) in High Wycombe, United Kingdom

Regulatory Executive

Location : High Wycombe, UK

Main Responsibilities

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

patients.

  • 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

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.

  • SME on given topic and author of relevant SOPs

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.

  • Proactively shares key regulatory insights with CVT help shape brand strategy

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

  • 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

efficiency gains.

  • Actively contribute to increasing the regulatory expertise of the team by mentoring of

junior regulatory colleagues

Qualifications

Job Requirements

  • 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.

Primary Location

United Kingdom-England-High Wycombe-

Organization

Janssen Cilag Ltd. (7360)

Job Function

Regulatory Affairs

Requisition ID

2105885324W

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