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    Associate Director - Regulatory Affairs - Remote

    Buckinghamshire | Johnson & Johnson

    Job Details
    Category: Government & Defence
    Posted Today
    Associate Director - Regulatory Affairs - Remote
    Make sure to apply quickly in order to maximise your chances of being considered for an interview Read the complete job description below.
    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".
    Apply to this job.
    One step closer to getting hired!