Director of Regulatory Affairs in Durham, NC with Greene Resources

Date Posted: 2/3/2021

Job Snapshot

Job Description


Job Number: 39925


Director of Regulatory Affairs


Job Description:

We are seeking an experienced Director of Regulatory Affairs to join our client, a renowned global non-profit aimed at researching and improving the human condition. This person will play an instrumental role in the strategic planning and execution of critical development for Early Development programs for Drugs, Biologics, and/or Medical Devices. The ideal candidate will have strong Regulatory Affairs experience in a pharmaceutical, biotechnology, medical device, or CRO backgrounds. This is a Direct Hire opportunity that offers a comprehensive benefits package and the flexibility to offer a competitive salary based on experience.


Responsibilities:


  • Provide expert scientific input into the preparation of regulatory documents and interactions with regulatory authorities

  • Lead a robust Early Clinical Development pipeline and shepherd multiple programs through IND filing

  • Plan and execute product development plans in coordination with Sponsor and other team members

  • Develop and implement regulatory strategies, including the identification of gaps or risks, for drugs, biologics and/or devices across a range of therapies

  • Manage IND enabling activities and collaborate cross-functionally, including the facilitation of and partnership with preclinical safety assessment/toxicology, DMPK/bioanalysis, Manufacturing, QC/QA, and clinical teams to achievement of timelines and deliverables

  • Manage and identify key external collaborations that will enhance and/or expedite decisions on projects and/or yield new target opportunities

  • Facilitate oversight and management of vendors, partners, CROs, consultants and contractors in all aspects of project execution

  • Prepare teams for and lead the conduct of milestone development meetings with Regulatory Authorities

  • Provide interpretation of and advice regarding regulations, directives, and guidance

  • Manage IND assembly, managing the strategy, timelines, and implementation of IND assembly plans of eCTD, and filing of IND

  • Represent increasing levels of responsibility in different size work groups operating with different levels of autonomy and therefore experience required

  • Interpret existing and proposed regulatory

  • Assist with the resolution to questions of a regulatory nature

  • Disseminate regulatory information and updates

  • Implement regulatory training plans and initiatives


Education Requirements:


  • Ph.D. in a scientific or technical discipline with 10 years of progressively responsible experience in a pharmaceutical, biotechnology, Medical Device or contract research organization (CRO), including significant experience in a Regulatory Affairs leadership role; OR a Master's degree with 12+ years' relevant experience OR a Bachelors' degree with 15+ years of relevant experience.


Desired Background/Skills:



    Qualifications:


    • At least 10 years experience of progressively responsible experience in pharmaceutical, biotechnology, medical device, or contract research organization (CRO), including significant experience in a Regulatory Affairs leadership role

    • Demonstrated an ability to manage several projects at any given time, to work successfully in a cross-functional and highly collaborative team environment, and to communicate clearly and effectively both verbally and in writing to a variety of audiences

    • Prior experience and success with filing INDs, briefing packages, and amendments required during IND and lifecycles

    • Ability to think strategically and critically to evaluate risks to regulatory product development and approval

    • Comfortable with setting strategies as well as taking a hands-on approach to all regulatory activities

    • Experience authoring technical reports, drug discovery documents, and regulatory submissions (Pre-submission, Pre-formal meeting, IND, IDE, NDA, BLA)

    • Experience in managing people within a matrixed organizational structure

    • Prior experience and success with filing NDAs, BLAs, 510ks or PMA highly desirable

    • Previous project leadership in drug discovery highly desirable


    Other Information:




      HR Directions is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
      This client is a U.S. government contractor with controlled-access facilities and must register non-U.S. Persons; therefore, all visitors to their facilities must declare their nationality and citizenship upon arrival at, and before entering their facilities. All candidates selected to interview will be required to complete 'Government Contractor Controlled-Access Facility Questionnaire' before visiting the client facility.