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CONFIRM
NEW
Dec 30 — 2021

Vice President, Global Head of Regulatory Affairs

Department:Clinical Development Location: Alameda, CA, USA Job Type: Full-time Reports to: Chief Medical Officer

About the role

Reporting to the Chief Medical Officer (CMO), the Vice President (VP), Global Head of Regulatory Affairs will be responsible for leading and implementing strategic and operational regulatory activities for Acepodia’s portfolio which includes assets ranging from pre-clinical to clinical-stage assets. They will be responsible for the global regulatory strategy for the development of all compounds, including current and future indications. They will also play an important role in maintaining effective communication and constructive working relationships with both internal and external collaborators including regulatory authorities globally.

These activities include acting as the regulatory representative, and/or overseeing reports acting as such, on core teams, developing and planning regulatory submission strategy, coordinating the preparation of submissions to regulatory agencies, and conducting regulatory intelligence activities. The VP will work closely with key leaders throughout Acepodia in order to interact with regulatory agencies and ensure the timely preparation of scientifically valid submissions.

Education / Background

  • Masters, PhD and/or M.D. in a relevant scientific area is a plus but not required.
  • 10 years or more of biopharmaceutical leadership experience in regulatory affairs.

Responsibilities include, but are not limited to

  • Responsible to help develop global regulatory strategy for all programs and plans for execution.
  • Manage regulatory activities for assigned projects, including representation on the core/project development teams.
  • Participate in meetings and interact with leaders of core/project teams to convey regulatory requirements and develop a strategy to meet corporate goals.
  • Serve as the primary interface for FDA, EMA and other regulatory agencies on assigned projects.
  • Experience in the preparation and submission of BLA/NDA/MAA's for submission within expedited timelines across the regions.
  • Proven ability to dissect complex issues to quickly distill key issues for discussion with regulatory authorities and guide teams (internally/externally) in the preparation of responses to regulatory questions.
  • Lead the regulatory submission teams for projects assigned within defined time schedules and following established standards.
  • Represent the Regulatory Affairs team in interdepartmental meetings and before the Board of Directors (if appropriate).
  • Oversee the regulatory collaboration with CROs or other partnering organizations and coordinate international submissions to meet regulatory requirements.
  • Maintain knowledge of global competitive landscape, regulatory environment, regulations, and guidelines.
  • Develops and mentors teams to provide project teams with strategic regulatory guidance to expedite product development, registration, and through life cycle management.
  • Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
  • Ability to collaborate closely with senior leaders within Clinical Development, Commercial, and other key areas to develop regulatory strategies to align with business objectives. Provides strategic leadership and vision to the Regulatory department.

Position Requirements & Experience Relevant Skills & Experience:

  • Experience managing and leading the regulatory affairs function in a biopharmaceutical company, including outside consultants, and providing strategic leadership and operational excellence. Experience developing broad regulatory plans for IND through phase IV and correlating filings.
  • Demonstrated track record serving as the primary point of contact for global regulatory agency interactions, including the preparation and regulatory leadership for key meetings, pre-IND, IND, Phase I-IV, and pre-BLA/NDA.
  • Demonstrated track record of regulatory submissions. Manage the preparation and timely submission of regulatory documents, including INDs, briefing documents for key meetings, NDAs/BLAs, Orphan Drug Applications, Dossiers, responses to regulatory requests, and required periodic reports.
  • Rich regulatory knowledge and experience with clinical, nonclinical, CMC, and labeling aspects of development programs. Experience with multiple oncology therapeutic areas and modalities (antibodies, biologics, and cell therapies).
  • Demonstrate a commitment to Acepodia values of Integrity, Commitment, Creativity, Teamwork, Accountability, and Fun

Acepodia is an equal opportunity employer offering a competitive salary and comprehensive package, including stock options, medical care, paid vacation, and holiday time. Title and salary commensurate with experience.

About Acepodia

Acepodia is a clinical-stage biotechnology company developing NK and NK-like gamma delta T cell therapies using our patented ACC (Antibody Cell-Conjugation) technology platform. Using ACC technology, we arm immune cells with antibodies to target and eradicate cancer cells. Our mission is to develop safe, effective, and affordable cell therapies to fight and beat cancers.

Founded in 2017 in the birthplace of biotechnology, the San Francisco Bay Area, CA. Acepodia is venture capital and private equity backed and funded. Our platforms and products aim to address and overcome the major obstacles in cancer therapy: Ability to target low expression of tumor antigens to better prevent tumor escape; Trafficking of effector cells to tumor locations; Activate the immune system to attack cancer cells.
 

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