Senior Vice President, Regulatory Affairs

Catalyst is seeking an accomplished Senior Vice President, Regulatory Affairs to serve as a member of the senior management team reporting to the Company's President & Chief Executive Officer. The successful candidate will work closely with the CEO, the Board and other members of the SMT to develop and advance Catalyst's regulatory vision. The SVP, RA will have responsibility for driving the regulatory strategy that helps advance the clinical development of Catalyst's pipeline programs and will be an important external "face" representing the Company with global regulatory agencies.

Responsibilities

Develop global regulatory strategy for marketing applications.

Lead the development of regulatory submissions for FDA, EMA and other international agencies.

Directly manage a small, growing team within the Regulatory Affairs function to ensure Company's compliance with applicable internal standards, FDA and other regulations, and associated requirements for pharmaceutical development.

Pro-actively drive communications with all regulatory bodies to obtain all necessary IND's and other regulatory pre-approvals for clinical research, as well as BLA/MAA approvals for Company products on a timely basis.

Oversee the required regulatory processes for studying investigational drugs.

Serve as the primary liaison to US and international regulatory authorities for site inspections, presentations, submissions, and compliance matters.

Guide the establishment of procedures and processes that ensure document compliance with Regulatory Company guidance/template specifications and data standards.

Establish, develop and implement a pharmacovigilance system to ensure the clinical quality, efficacy and safety of all Catalyst products.

Oversee Regulatory Affairs product files to support compliance with all regulatory requirements.

**Title/Level to commensurate with educational and professional experience.

Requirements

BS degree in any of the physical and life sciences required. Advanced degree and/or professional certification preferred.

15+ years in the pharmaceutical industry with direct regulatory experience in submissions and FDA interactions for new drugs (must include large molecules, including INDs, BLAs).

Biologics expert with knowledge of current FDA and EMA laws, rules and relevant guidance documents specifically relating to biologics.

Previous Orphan Drug experience required.

Global experience with prior success interacting with US and EU regulatory authorities required; previous experience dealing with Blood Products Advisory Committee would be ideal.

Accomplished leader and manager, ideally having effectively scaled an organization appropriately over time.

Extensive knowledge of U.S. and International regulations including cGMP, GCP, GLP, ICH guidance documents.

Experience managing consultants and contractors and ensuring the integrity and timeliness of their work.

Extensive knowledge and experience with eCTD regulatory filings/ FDA electronic submissions.

Strong understanding of Drug Development R&D, manufacturing, laboratory, and Quality Systems.

Previous participation in package insert negotiations.

Specific blood product experience, hemophilia and hemostasis therapies and experience with a subcutaneously administered agent, considered a plus.

Personal characteristics and culture fit

Executive presence, with excellent written, verbal and interpersonal skills to interact effectively internally with the Senior Leadership team and Board of Directors and externally with regulatory agencies.

Dynamic, strategic leader who will thrive in an entrepreneurial, fast-paced business environment.

Team player with ability to drive breakthrough results with passion, confidence, tenacity, and personal responsibility.

Motivated person of vision, integrity, energy, collegiality, and leadership.

Strong personal character coupled with a broad regulatory and scientific acumen, organizational skills and intellect.

Entrepreneurial spirit and commitment to collaboratively working "hands on" as needed to achieve corporate objectives.