Senior Regulatory Professional

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.

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, we offer you a strategic leadership role in a highly dynamic environment.

You will drive the regulatory strategy and be accountable for regulatory submissions for our exciting developing pipeline to serve our UK patients.
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.


* Assists 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


* Helps 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

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 ...