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Senior Associate - Regulatory Affair

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Job Description


Janssen is part of Johnson & Johnson, one of the biggest and most respected health care companies in the world. Who is Janssen? 


We’re people; more than 35,000, working hard to treat, cure, stop and prevent some of the most devastating and complex diseases — from diabetes and HIV to Alzheimer’s and cancer. Janssen is dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolism. We are driven to action by the plight of patients, and we seek to make a positive impact on their lives. That’s why we never limit the search for new medicines to our own four walls—we’re always looking to work with partners interested in helping us achieve our goals.

We are looking for a Senior Associate Regulatory Affair to join our Global Regulatory affairs team based in the UK.


Responsibilities:

1. Input in Development, Post-Approval & Life Cycle Management


- Participate in global regulatory team meetings as appropriate

- Advise the Regulatory team on applicable regulatory requirements, project-specific regulatory issues as assigned

- Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area


2. Liaison with Regulatory Agencies & Local Operating Companies (LOC)


- Act as back-up for contact with Regulatory Agencies as needed


- Draft cover letters for Regulatory Agency communication

- Help in the preparation of meetings with various agencies.

- Liaise with LOCs, track and respond to queries in a timely manner


3. Input in documents & process development


- Assist in the development of processes related to regulatory submissions

- Draft and review some document content (depending on the level of regulatory knowledge/expertise)

- Provide input to documentation ensuring their accuracy while answering the questions being posed

- Track dates of submissions and Regulatory Agency responses


4. Clinical Trial Applications (CTA)


- Review protocols and ensure alignment with regulatory requirements

- Advise team on required documents and submission strategies in preparation of CTAs and ensure CTA submission packages are complete and available according to agreed timelines.

- Review and approve clinical trial supply plans.


5.  Marketing Authorization Applications (MAA)


- Provide regulatory support throughout the registration process and provide regulatory support throughout life-cycle management

- Advise team on required documents and submission strategies in preparation of MAA as assigned (in collaboration with LOCs as appropriate)

- Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities

- Assist with submission and acceptance of MAA

- Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans



Qualifications

- A university degree in medical or pharmaceutical sciences or related field

- Have about 3 years plus experience in regulatory affairs working with multiple teams.

- Experience in developing regulatory submissions, drafting and reviewing document contents and providing input to regulatory documents to ensure they are accurate.

- You will have experience in providing support throughout the registration process and life-cycle management.

Location: High-Wycombe, UK

What’s in it for you?

“Caring for the world, one person at a time…”

As an employee, we consider you as our most valuable asset. We take your career seriously.

As part of a global team in an innovative environment, your development is key and our day-to-day responsibility.


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
1905776444W