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Job Function: Regulatory Affairs Group
Job Sub Function: Regulatory Affairs
Job Category: Professional
All Job Posting Locations: GB006 High Wycombe
Job Description:
Janssen is recruiting for a UK Senior Regulatory Professional, located in High Wycombe. We work in a hybrid environment in order to keep a healthy work-life balance.
Key Responsibilities:
Provide regulatory leadership for a portfolio of promoted products
* Partner with local and global teams to provide regulatory strategic and technical expertise for submissions, HA interactions, and brand strategy.
* Leads in managing, preparing, and submitting new MAA, ILAP IP, TDP, and UK PIPs and other local submissions as assigned.
* Support health authority meetings for local activities.
* Accountable for the content of the local labeling documents released to prescribers and patients.
* Supports regional and local businesses with the collection of RA competitive intelligence as required.
* Build positive relationships with Health Authority colleagues to enable product strategies.
Departmental management
* Individual contributor role reporting to Regulatory Manager.
* Coach and mentor team members, driving performance through enablement.
* Leads the adoption and implementation of new systems and processes to streamline routine regulatory activities.
Compliance
* Establish and implement compliance excellence with all regulatory requirements.
* Develops and maintains in-depth knowledge of regulations/legislation.
* Be up-to-date with and adapt early to local changes in the regulatory environment.
Qualifications
Education:
* University Degree or equivalent experience in Pharmacy, Biology, Chemistry, or related Life Science
Experience and Skills:
Required:
* Strong technical Regulatory Affairs and Regulatory Strategy Experience.
* Direct experience and confirmed understanding of EU/UK requirements and guidelines.
* Significant persuading, influencing, strategic, and negotiating skills.
Preferred:
Other:
* Advanced English language
* Limited Travel
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