Associate Director, Emea Regulatory Affairs Gene - High Wycombe, United Kingdom - Johnson & Johnson

Johnson & Johnson
Johnson & Johnson
Verified Company
High Wycombe, United Kingdom

2 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

The Janssen EMEA Regulatory Affairs team is looking to recruit an
EU Regulatory Affairs Expert within the
Neuroscience, Cardiovascular, Metabolism ,
and Retinal (NCM&R) therapy area team.

We are looking for an Associate Director in Regulatory Affairs to provide strategic and tactical regulatory input for a range of exciting gene therapy products.


Description:


Key Responsibilities:


1.

Develop regulatory strategies for innovative new medicines:

  • Develop and drive implementation of regional regulatory strategies in support of the global development plan
  • Drive the Target EU SmPC based on an understanding of the regional regulatory strategy
  • Ensure implementation of scientific advice/Regulatory Agency comments into the product development plan

2.

Work with Regulatory Agencies and Local Operating Companies:

  • Establish strong working relationships with regulators to lead effective interactions on clinical study design, submissions content, productspecific labeling, and postapproval commitments
  • Act as primary contact with EMEA. Work through LOC and/or CRO for National Regulatory Agencies contacts, as appropriate
  • Define attendance in consultation with GRL and CDT. Ensure timely and accurate feedback to the business
  • Ensure that issues raised by Regulatory Agencies are promptly and adequately addressed

3.

Input in document and process development:

  • Provide advice on submission requirements for the EMEA region
  • Plan and develop briefing documents for meetings Regulators
  • Provide input to and review submission documents to ensure that they are fit for purpose and support the target label
  • Define, generate, and submit appropriate datadriven (regional/local) responses to Regulatory Agency questions
  • Plan and track regulatory activities in company systems

4. Clinical Trial Applications (CTA):


  • Ensure protocols support registration, reimbursement, and competitive labeling
  • Guide crossfunctional team on EMEA CTA requirements
  • Ensure CTA submissions are complete and available according to agreed timelines

5. Marketing Authorization Application (MAA):


  • Provide regulatory leadership throughout the registration process and postapproval
  • Manage submissions, define submission plans, and advise the team on required documents and submission strategies in preparation for MAAs (in collaboration with LOCs as appropriate)
  • Ensure timely MAA availability, track critical path activities
  • Responsible for submission and acceptance of MAA
  • Ensure countryspecific submission packages are made available to the LOCs

6.


Resource Planning and Management:

  • Determine resource requirements for assigned projects and anticipate needs for major filings
  • Provide guidance and coaching to a small team of junior Regulatory Professionals

Qualifications:


Qualifications:


Education and experience:


  • University degree medical or paramedical (pharmacy, biology, veterinary or equivalent )
  • Regulatory experience in drug development and commercialization
  • Experience with EU regulatory procedures (CP, MRP, national)
  • Experience in working in project teams and/or a matrix organization

Skills:


  • Negotiating and conflicthandling skills
  • People management skills
  • Project management skills
  • Oral & written communication skills
  • Organization & multitasking skills

Knowledge:


  • Excellent knowledge of English
  • Knowledge of the applicable therapeutic area
  • Indepth knowledge of the regulatory environment, guidelines, and practice of EMEA regions


For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.

Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feel that they belong and can reach their potential.

No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong"

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.

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