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Sr. Director, Regulatory Affairs

Sr. Director, Regulatory Affairs

  • Location

    London, England

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    competitive benefits, short and long terms incentives

  • Contact:

    Vladyslav Babych

  • Contact email:

    Vladyslav.Babych@volt.eu.com

  • Job ref:

    73476-PHARM-VLB_1562603379

  • Published:

    3 months ago

  • Expiry date:

    2019-08-07

  • Start date:

    Q 3 2019

  • Consultant:

    #

Tasks and Responsibilities:

- Accountable for the development and implementation, of the regulatory strategy for products at a regional or global level, and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labelling in keeping with the properties of the product(s) ;
- Lead and develop a regional and/or global regulatory strategy that is reflective to international regulations and meets needs identified by the Sponsor.
- Conduct assessments such as regulatory gap analyses, considerations and strategy, risk planning and mitigation;
- Lead the development and implementation of innovative strategies to maximise the likelihood of regulatory success;
- Serves as the single point of contact with Sponsor and internal teams for selected projects, with key contributing members from department staff;
- Accountable for the delivery of regulatory milestones including assessment of the probability of regulatory success together with risk mitigation measures;
- Accountable for post-market application maintenance and compliance activities;
- Partner with department staff to influence developing views/guidance within leading Health Authorities on specific topics of relevance to their project or regulatory more generally;
- Lead the regulatory staff working on a product/project to ensure high productivity activities and successfully delivery meeting time and quality standards;
- Ensure effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements;
- Leads regulatory strategic development, communication and updates and ensures appropriate consultation and peer review;
- Provide regulatory leadership as needed in early development and due diligence review projects;
- Participate in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project;
- Manage relationships with competent authorities through frequent interaction;
- Provide regulatory review of study protocols, investigator's brochures, labelling, and integrated summary documents;
- Collaborate with US regulatory to develop global approval strategies
- Maintain up-to-date knowledge of regulatory requirements; and
- Supervise, develop, and mentor regulatory personnel

Experience and qualifications requirement:

- Preferred life science higher degree : PharmD, MD, and/or PhD. Other degrees may be considered;
- Over 10 years of experience in regulatory drug development including product approval/launch, where at least 5 years in management and leadership role
- Expert knowledge of regulatory affairs within range of therapeutic areas;
- Previous experience in attending and/or helping a team prepare for a Major Health Authority interactions (e.g. EMA, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.);
- Significant experience in pharmaceutical and/or medical devices industries;
- Proven leadership and program management experience;
- Strategic thinking and ability to critically evaluate risks to regulatory activities;
- Successful contribution to a major regulatory approval at a global or regional level;
- A scientific and clinical understanding of the regulatory sciences;
- Excellent oral and written communication skills