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Regulatory Affairs Director

Reference Number: 2821
Location: Northeast

Our client is a major global healthcare company.  They have asked us to assist them in their search for a Regulatory Affairs Director.

The Regulatory Affairs Director (RAD) is accountable for the development and implementation of the regulatory strategy for a product/group of products and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients.  The RA Director possesses strategic leadership skills, has an understanding of regional and/or global regulatory science and overall drug/biologic development processes and strategies.  Experience and knowledge of the disease area is an important enabler to being able to influence cross-functional discussions with regional and/or Global Product Teams (GPT), Investigational Product Teams (IPT) and relevant stakeholders.  As necessary, the RAD may also take on the Global Regulatory Lead (GRL) role for a product/group of products.

Major tasks and responsibilities will include:

  • Accountable for the development and implementation, at a regional or global level, of the regulatory strategy for a product/ group of products and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the business and patients.
  • Develops a regional and/or global regulatory strategy that is reflective of applicable domestic and international requirements.
  • Owns the planning and construction of the global dossier and core prescribing information.
  • Conducts regulatory risk planning and mitigation.
  • Develops and implements innovative strategies to maximize the likelihood of regulatory success.
  • Serves as the single point of contact and Global Regulator Affairs (GRA) representative on Regional and/or Product Development Teams (PDT)/Global Product Teams (GPT).
  • Leads the Global Regulatory Sub-team (GRST) with key contributing members from a regional perspective, emerging markets, RA CMC as well as delivery & enablement. Through the GRST, ensures that regional regulatory needs are identified and incorporated into an optimum Global Regulatory Strategy that in turn contributes to the Global Product Development Plan.
  • Accountable for the delivery of regulatory milestones including assessment of the probability of regulatory success together with risk mitigation measures.
  • The Global Regulatory Leader is also accountable for product maintenance, supply and compliance activities associated with marketed brands.
  • Leads/ be part of the objective assessment of emerging data against aspirations and updates senior management on project risks/mitigation activities.
  • Partners with marketing company staff to influence developing views/guidance within leading Health Authorities on specific topics of relevance to their project or regulatory more generally.
  • Leads the regulatory staff working on a product/project to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality.
  • Ensures effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements.
  • Develops, communicates and updates the Regulatory Strategy Document for assigned products/projects.  Ensures appropriate consultation and peer review.
  • Monitors changes in the regulatory environment, both general and specific to the therapeutic area and supports and advises regional and/or Global Product Teams accordingly.
  • Provides regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
  • Participates in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project.
  • Regional RAD is accountable for interacting with the regional commercial and cross-functional teams to ensure business needs are understood within the GRST and to ensure regional commercial engagement with the proposed regulatory strategies/risks/mitigation plans.

We seek candidates with the following qualifications:

  • Bachelor’s degree in a science related field and/or other appropriate knowledge/experience.
  • Previous experience in attending and/or helping a team prepare for a Major Health Authority interactions (e.g. FDA advisory committee meetings, oral explanations, scientific advice, Pre-NDA/BLA, EOP2 meetings etc.).
  • Significant experience or equivalent of regulatory drug development including product approval/launch. Expert knowledge of regulatory affairs within one or more therapeutic areas.
  • Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority.
  • Proven leadership and program management experience.
  • Ability to think strategically and critically evaluate risks to regulatory activities.
  • Ability to work strategically within a complex, business critical and high profile development program.
  • Successful contribution to a major regulatory approval at a global or regional level.
  • A scientific and clinical understanding of the regulatory sciences.
  • Must demonstrate strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2821. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.