Job Summary

The VP Regulatory Affairs will be the most senior Regulatory Affairs employee at Affini-T and will be accountable for a broad range of regulatory activities.
The VP will set the regulatory strategy for the entire pipeline as well as individual programs. Responsibilities include management of external Regulatory Affairs consulting vendors; hands-on coordination, writing, and reviewing of regulatory documents, and representation of the company at regulatory meetings, such as FDA interactions (pre-IND, IND, RMAT, etc).
This VP will contribute to the creation of the overall product development strategy and the management of the development, monitoring and delivery of regulatory project plans.
In addition, this VP will provide functional support for due diligence initiatives, investor and partner discussions, including opportunity and risk assessments.
Key areas in scope include CMC (focus on autologous cell therapy), pre-clinical and clinical pharmacology, translational, in-vitro diagnostic, and clinical trial activities.
This VP will work closely with the respective internal cross-functional partners.
The successful candidate will have several years of experience in Regulatory Affairs with a focus on early-stage drug development and ideally drug approvals, both in a large pharmaceutical company and a biotech environment.
A fundamental scientific understanding of the cell, gene, and immune therapy space is required.
Experience with viral and non-viral gene-edited cell products is a plus.
This position will be in our Boston/Watertown office.
Some travel may be required. A remote working option with some on-site presence in the Boston/Watertown office can be considered for an outstanding candidate.

Accountabilities

The successful candidate will play a key role in building Affini-T’s Regulatory Affairs function and processes to support our pre-clinical and clinical stage products ensuring compliance with regulations.
Creating, developing, and implementing regulatory strategies and managing US & global regulatory submissions to ensure that pipeline programs are advanced in a timely and compliant manner.
Up-to-date regulatory knowledge and a creative mindset are important qualities to establish innovative drug development strategies for our pipeline.
The VP Regulatory Affairs will serve as the primary point of contact for global regulatory agencies with responsibility for all regulatory agency submissions, meetings, action items, and communications.
Provide regulatory leadership and support to project/program teams and Senior Management for all aspects of our development programs (e.g., nonclinical, clinical, quality, CMC)
Provide key updates and guidance on regulatory activities to Executive Team and Board of Directors, as needed.
Effectively communicate requirements and compliance obligations under laws, regulations, and guidance in the US and around the world.
Direct and negotiate submissions (INTERACT, pre-IND, IND, CTA, NDA, MAA etc..) and approvals with regulatory authorities.
Support development of process design, manufacturing, analytical, and supply chain strategies for cell therapy and biologics drug substance/drug products, viral and non-viral vector drug substance intermediates, and critical reagents through expert regulatory guidance to enable global implementation.
Strategize, lead, write and/or supervise the development and submission of documents/dossiers to regulatory agencies to achieve development goals; ensure on-time, high-quality and regulatory–compliant submissions.
Provide support to regulatory reviews for due diligence initiatives, including opportunity and risk assessment.
Contribute to the creation of the overall product development strategy and manage the development, monitoring and delivery of regulatory project plans throughout the life cycle.

Qualifications

The successful candidate should have a track record of successful interactions with regulatory agencies, as demonstrated by timely submissions and ideally approvals of pharmaceutical/biotech compounds, with a focus on oncology and gene & cell therapies.
Advanced degree in life sciences preferred. Mandatory hands-on experience supporting both early and late phase drug development, including development and filing of associated regulatory submissions.
Experience in a start-up environment with a balance of risk taking and advancing products efficiently.
Experience with drug -CDx co-development Experience managing and collaborating with outside partners/vendors. Ability to collaborate effectively with internal and external key stakeholders.
Ability to review, understand, and explain the regulations and guidance documents to guide project teams. Proven success in communicating to and negotiating with FDA and global health authorities and managing clinical trial applications in the US and other geographies around the world.
Ability to drive meetings with various stakeholders: (i) senior management, (ii) regulatory agencies (iii) investors, (iv) expert advisors (v) collaborators and (vi) project teams.
Passionate, patient-centric, intrinsically motivated, outcomes-oriented and innovative. Outstanding written, oral, organizational, and interpersonal skills are required for this highly collaborative role.
Strong understanding of the drug development process.
Stature, experience, technical credibility, strong relationship management and interpersonal skills to quickly gain confidence both with internal stakeholders (CMC, preclinical, clinical, business development, legal, etc.) and externally among regulatory agencies.
An individual who can influence strategic direction of complex global regulatory issues, solicit information, listen well, persuade others, make important decisions and shape outcomes.
Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player. An individual who demonstrates humility, good judgment, and strong analytical skills and adjusts quickly to changes. Excellent organizational and project management skills and ability to think strategically. A person of the highest integrity.

About Affini-T Therapeutics

Affini-T Therapeutics is an emerging biotechnology company focused on building a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic mutations is used to develop solid tumor therapies. Through the application of gene editing and synthetic biology, our focus is enhancing T-cell fitness to overcome the immunosuppressive tumor microenvironment.

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Affini-T Therapeutics

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