Associate Director - Regulatory Affairs - Remote

Associate Director -  Regulatory Affairs - Remote

This role is based at high Wycombe ideally however we will consider fully remote candidates but you must be based in the UK or Ireland. 

This is a part time role, hours will vary between 24 - 32 hours per week.

The Company:

Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

Duties and Responsibilities:

Strategic and tactical input in development, post-approval and Life cycle management

• Advise the Project Team and/or Regional Therapeutic Area Leader on applicable regulatory issues, project-specific regulatory issues, and issues related to regional regulatory climates

• Drive understanding of central and national regulatory requirements

• Develop and ensure effective implementation of regional (central and national) regulatory strategy and tactics in support of the global development and life-cycle management plan

• Develop a deep understanding of the regional regulatory environment, competitor intelligence and therapeutic area

• Provide input for developing and updating the Target EU SmPC based on an understanding of the implications of regional regulatory strategy for labeling

• Ensure appropriate implementation of scientific advice / Regulatory Agency comments into development and life-cycle management plan

Liaison with Regulatory Agencies and Local Operating Companies

• Establish and maintain strong relationships with Regulatory Agencies and effectively negotiate with Regulatory Agencies on product-specific labeling, study design, submissions content, and post-approval commitments

• Act as primary contact with EMEA. Work through LOC and/or CRO for National Regulatory Agencies contacts, as appropriate

• Ensure appropriate involvement and liaise with LOC regulatory affairs personnel to facilitate local Regulatory Agency meetings

• Determine timing and strategy for Regulatory Agency meetings and scientific advice

• Prepare team, manage, conduct and facilitate contacts/meetings with Regulatory Agencies. Define attendance in consultation with GRL and CDT. Issue minutes and contact reports and disseminate correspondence, faxes, contact reports from contacts with Regulatory Agencies

• Ensure that issues raised by Regulatory Agencies are promptly and adequately addressed

• Negotiate labeling with Regulatory Agencies, going through each of the back-up strategies if necessary

Input in document and process development

• Advise team on required documents and processes to support Regulatory Agency contacts and submission

• Plan and develop briefing documents for meetings with Regulatory Agencies, including determining content and review of documents

• Provide input to and review submission documents to ensure that they are fit for purpose and support labeling statements as appropriate

• Define, generate and submit appropriate data-driven (regional/local) responses to Regulatory Agency questions

• Ensure necessary regulatory activities are planned and adequately tracked in company systems

Clinical Trial Applications (CTA)

• Ensure protocols are developed in alignment with regional registration strategies to support registration, reimbursement and competitive labeling

• Advise team on required documents and submission strategies in preparation of CTA

• Ensure CTA submission packages are complete and available according to agreed timelines

Marketing Authorization Application (MAA)

• Provide regulatory support throughout registration process

• Provide regulatory support throughout life-cycle management

• Manage submissions, define submission plans, and advise team on required documents and submission strategies in preparation of MAAs (in collaboration with LOCs as appropriate)

• Ensure timely MAA availability, track critical path activities

• Responsible for submission and acceptance of MAA

• Ensure country-specific submission packages are made available to the LOCs

Resource Planning and Management

• Determine resource requirements for assigned projects and anticipate needs for major filings

• Provide line management, coaching and guidance to Regulatory Professionals as appropriate

Job Requirements

Education and experience

• University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience

• Breadth of regulatory experience in drug development and commercialization (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas)

• Experience with EU regulatory procedures (CP, MRP, national)

• Experience in working in project teams and/or a matrix organisation

Skills

• Negotiating and conflict handling skills

• People management skills

• Complex project management skills

• Oral & written communication skills

• Organization & multi-tasking skills

Knowledge

• Excellent knowledge of English

• Knowledge of the applicable therapeutic area

• In depth knowledge of the regulatory environment, guidelines and practice of EMEA regions

You must be able to demonstrate experience in the following to be considered for this role, please ensure this is visible on your application/work history when applying, it will also be discussed in more detail with the recruiter in a screening call.

1.       Strategic and tactical input in development, post-approval and Life cycle management (MAA experience) 

2.       Liaison with Regulatory Agencies and regional / cross-functional teams

3.       Input in document review and revision

4.       Clinical Trial Applications (CTA)

5.       Complex project management skills

6.       Negotiating and conflict handling skills

7.       People/matrix management skills

In Return:

In return for this role you will receive a very competitive hourly rate. A minimum 12 month contract  & an opportunity to work with a Global Leader within the Pharmaceutical sector, Johnson & Johnson. 

Things to remember before applying for this role:

• This role is INSIDE IR35 (UK only)

• We do not accept applications via email.

Thank you very much and we look forward to receiving your application. 

Diversity, Equity & Inclusion:

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 one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.