Senior Vice President, Regulatory Affairs

About AskBio

Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered.

At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.

We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform people’s lives.

Our principles:

  • Advance innovative science by pushing boundaries.
  • Bring transformative therapeutics to patients in need. 
  • Provide an environment for employees to reach their fullest potential. 

Our values:

  • Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
  • Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
  • Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
  • Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
  • Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.

We have an opportunity for a Senior Vice President, Regulatory Affairs to join the AskBio team and  be part of our continued success!

Position Overview 

The Senior Vice President, Regulatory Affairs, reporting to the Chief Medical Officer/Chief Development Officer, will lead and oversee the global regulatory process for all AskBio programs including responsibility for overall regulatory strategy, regulatory risk assessment, and regulatory interactions on behalf of AskBio. This role is both strategic and operational, requiring the ability to build and lead a word-class regulatory affairs team and provide operational excellence to both early and late-stage development programs while partnering with internal and external stakeholders to ensure quality and timely global regulatory submissions and approvals. This position can be based at AskBio’s US facilities (Durham, NC and Philadelphia, PA) or be US-based, remote.

Responsibilities

  • Provide regulatory guidance, direction, and leadership on corporate regulatory strategies and execution for all the development programs.
  • Make strategic contributions to the development and implementation of product development plans and partner with Translational Medicine, Clinical Development, Clinical Operations, Portfolio and Project Management, and CMC functions to set up and achieve the development objectives.
  • Prepare, review, or sign-off key regulatory meeting requests and briefing documents and lead the preparation and interactions with regulatory authorities.
  • Provide leadership and oversight to the preparation of all global regulatory submissions (from INDs to marketing applications) to the FDA, EMA, PMDA, and other global regulatory agencies, including gene therapy products and companion diagnostic tests.
  • Manage on-going regulatory submission and reporting requirements.
  • Provide innovative approaches to resolve complex regulatory issues and increase speed to patients.
  • Provide leadership and oversights for all regulatory interactions.
  • Maintain up-to-date working knowledge of US laws, regulations, and guidelines as well as familiarity with the global regulatory environment and share the updates with relevant functions and colleagues.
  • Represent the regulatory function on cross-functional development team(s) and senior management meetings.
  • Establish, update, and implement regulatory policies, standards, and procedures for the company for quality and compliance.
  • Partner with Clinical and Manufacturing Quality and Clinical Operations to ensure operations are compliant with FDA, ICH, EMA, and industry standards.
  • Manage the regulatory aspects of products and projects including achievement of timelines and deliverables.
  • Build and lead the regulatory affairs organization to support the growing portfolio/pipeline.

Required Education and Experience

  • Bachelor’s Degree in Life Sciences or related-field.
  • 15+ years’ biopharmaceutical experience, including at least 10 years of direct experience in Regulatory Affairs.
  • Track record of successful IND/CTA, NDA, and/or BLA submissions and approvals.
  • Extensive knowledge of clinical development, regulations/guidelines of FDA, EMA, ICH and PMDA and GxP.
  • Proven leadership abilities with prior experience in building and leading Regulatory Affairs teams.
  • Experience in global submissions and approvals in Europe and Asian-Pacific.

Preferred Experience and Skills

  • MD or PharmaD, PhD or Regulatory Affairs Certification (RAC).
  • Experience in gene therapy research and development.
  • Ability to blend analytical and critical thinking skills to enable data-driven, strategically oriented review of regulatory documents.
  • Excellent verbal and written communication skills, including the ability to negotiate with internal and external stakeholders.
  • Ability to multitask among multiple projects and teams and work independently in a fast-paced, highly interactive environment.
  • Self-motivated, organized, capable of working independently and in a collaborative environment with cross-disciplinary teams.
  • Track record and willingness to mentor direct reports and cross-functional colleagues.
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.

Asklepios BioPharmaceutical, Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or emailing us at talent@askbio.com.