Vice President, Regulatory Affairs

Schedule: Full-time
Location: Remote
Reports to: Chief Medical Officer

Who we are:

If you’re looking for a typical biotechnology company, you’ve come to the wrong place.

We are a revolutionary biotherapeutics company and our mission is to revolutionize autoimmune and allergic disease treatment by resetting the immune system for superior long-term disease remission.

How?

By developing therapies that achieve superior long-term disease remission from less frequent chronic dosing and without suppression of the immune system. A goal that others haven’t been able to reach.

Why?

Existing therapies for autoimmune and allergic diseases require frequent chronic dosing, provide only short-term disease remission in a limited number of patients and suppress the immune system, ultimately putting patients at risk of developing serious infections and life-threatening side effects.

How you’ll contribute:

Reporting to the Chief Medical Officer, the Vice President, Regulatory Affairs will join our team in a permanent leadership capacity.  This role will be responsible for leading the regulatory strategy and execution of our unique platform as well as providing cross-functional leadership for the organization.

This is a unique chance to build a Regulatory function and team from the ground-up for a cutting-edge immunology company with a high-powered, seasoned executive team where you will play a key leadership role in the organization. 

Principal Duties and Responsibilities:

  • Develop the global regulatory strategy for individual programs including preparing the programs for successful registration in all major global markets
  • Define country-specific regulatory strategies for all programs, assessing optimal route to approval, leading communication, and negotiation with global regulatory agencies, and leading the company’s effort in definitive submissions
  • Provide strategic regulatory leadership for all clinical development projects, including but not limited to, overall global regulatory strategy, regulatory requirements for registration in domestic and international markets, and regulatory risk assessments and mitigation for all Company programs
  • Lead communications and submissions with regulatory agencies, prepare briefing and regulatory documents for regulatory agencies (INDs, BLAs, and annual reports), respond to regulatory agencies with intelligence and diplomacy
  • Ensure that all nonclinical and clinical programs such as pharmacology, toxicology, and clinical trials are appropriately informed and structured to follow ICH guidelines and meet US, European, and other regulatory requirements
  • Ensure that all the manufacturing and quality programs relevant to the chemistry, manufacturing, and controls of pharmaceutical products, such as process and manufacturing development, validation plans, production, release, and labeling, are appropriately structured to meet US, European, and other regulatory requirements
  • Build collaborative partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through sharing of knowledge, expertise, and relevant information
  • Provide guidance and information to the Leadership Team on emerging trends, regulations, and health authority guidelines to ensure use of the desired regulatory strategies
  • Provide counsel, training and interpretation of FDA and other regulatory requirements to all Development and Commercial/Medical team members and where appropriate to other teams and individuals
  • Cultivate an atmosphere of transparency and problem-solving that encourages requests for advice and input by company staff
  • Work closely with Commercial/Medical to build a culture and systems to support reviews of promotional and medical communications and activities
  • Interpret and communicate regulatory expectations to internal and external stakeholders (including partners, CROs, CMOs, consultants, and contractors) to execute program objectives in compliance with applicable regulations
  • Develop and maintain strong relationships with key stakeholders and regulatory officials
  • Build a culture of compliance with all applicable policies regarding health, safety, and environmental policies

Minimum Education, Training, and Experience Required:

  • Bachelor’s degree in a scientific discipline required, advanced degree (MS/PhD/PharmD) desirable
  • 10-15+ years of industry experience, with at least 10 years working in regulatory affairs (regionally or globally)
  • Regulatory experience with biologics including delivery of major applications (such as BLA/MAA) and securing approval
  • Extensive US and ex-US experience
  • Demonstrated track record leading and growing a first-class regulatory function in a fast-paced, dynamic organization, prefer small company experience
  • Experience leading regulatory aspects of early and late-stage drug development through market launch
  • Extensive knowledge of the regulations, regulatory process and requirements in major global markets and expertise in preparing complex regulatory documents including INDs, milestone briefing packages, BLAs, and other major regulatory submissions
  • Ability to influence direction of complex regulatory issues –solicit information thoughtfully, listen well, persuade others to make important decisions and shape outcomes
  • Proven leadership with a strong results orientation, positive “hands on” attitude and a sense of urgency to get things done
  • Polished written, presentation, and communication skills

This position requires extended periods of sitting and working on a computer.  Must have the ability to navigate travel both internationally and domestic. 

Revolo Biotherapeutics is an Equal Opportunity/Affirmative Action Employer – EOE Minorities/ Females / Protected Veterans / Individuals with Disabilities.

Please send your resume and cover letter to cvincent@revolobio.com

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Glen Giovanetti

Non-Executive Director

Glen Giovanetti has more than 35 years of experience in strategy and operational leadership in the life science industry as well as in financial governance, risk and reporting as EY’s Global Biotechnology Sector Leader and Life Sciences Sector Leader. He currently serves on the Board of Directors of Life Science Cares, Teon Therapeutics and XW Pharma.

Marla S. Persky

Non-Executive Director

Marla S. Persky currently serves as the chief executive officer and president of WOMN LLC. She has more than 25 years of international senior business and legal experience in the pharmaceutical industry having held numerous business and legal positions at Boehringer Ingelheim and Baxter International. She currently serves on the Boards of Directors of Xeris Pharmaceuticals, YGEIA Consulting Group, Primary Stages, World Neighbors and A Better Chance in Ridgefield.

Dora Rau

Senior Vice President, Quality

Dora Rau brings 25 years of experience in development and commercial operations for drugs, biologics, devices and combination products to the team. She has held numerous executive-level quality positions, with expertise in building quality systems and in leading teams to attain successful regulatory authority inspection outcomes and product approvals.

Jonathan Gold

Chief Financial Officer

Over the last 25 years, Jonathan Gold has been an institutional venture capitalist, a public fund manager, a founder, an operating executive, and a board member for companies across sectors including life sciences. In those roles, he was active in the development, financing and mergers and acquisitions for numerous public and private companies.

Team Members

Michael Albisser

Non-Executive Director​

Michael is a partner of Metellus, a Zurich and London-based venture capital firm investing in technology and life sciences with ground-breaking potential. Having more than 25 years of experience in the finance area he is responsible for finance, tax, and deal structures. He serves on the board of various venture-backed companies.

Dr. Isaac Cheng, m.d.

Non-Executive Director

Dr. Isaac Cheng is currently an investment professional at Morningside, a venture capital and private equity institution based in Boston USA, and Shanghai China. Dr. Cheng focuses primarily on biopharmaceutical and healthcare investments. He has served on numerous public and private company boards.

Peter Greenleaf

Chairman

Peter Greenleaf currently serves as the chief executive officer (CEO) and member of the Board of Directors of Aurinia, (NASDAQ: AUPH / TSX: AUP), an autoimmune therapeutics company. He has held several other CEO and chairman roles. He is also currently a member of the Board of Directors of Antares Pharmaceuticals, Inc. (NASDAQ: ATRS) and Chairman of the Board of Directors of Biodelivery Sciences International, Inc. (NASDAQ: BDSI).

Marylyn Rigby

VP of Marketing and Investor Relations

Marylyn Rigby is an experienced pharmaceutical, biotech, and drug delivery professional. In addition to her expertise in marketing, public and investor relations, she has a successful track record with business development, licensing, public and private equity financing, strategy and other key corporate functions.

Nancy Vinh

VP of Clinical Operations

Nancy Vinh brings over 20 years of experience in managing early and late phase, international clinical trials for drugs, biologics, cell therapy and combination products across a wide range of therapeutic areas to the team. She has served as head of clinical operations and led registrational and label expansion trials execution.

Team Members

Dr. Clare Burgess

Chief Development Officer

Dr. Clare Burgess has 24 years of experience in clinical drug development as a pharmacologist and has worked across a wide range of therapeutic areas within the pharmaceutical industry. She has held multiple leadership roles and has led multidisciplinary teams across the world.

Jeff Myers, m.d., ph.d

Chief Medical Officer

Jeff Myers, M.D., Ph.D., has 20 years of experience in medical affairs, regulatory and clinical development within the biopharmaceutical industry, with focuses on cardiovascular, pulmonary, oncology, and inflammatory diseases.

Before entering the industry, he practiced as a congenital cardiac surgeon and served as the chief of pediatric cardiac surgery at Massachusetts General Hospital and as Associate Professor of Surgery at Harvard Medical School.

Team Members

Dr. Roly Foulkes

Chief Scientific Officer

A true drug discoverer, Dr. Roly Foulkes has 25 years of experience building and delivering innovative therapeutic portfolios within the immunology and inflammatory disease space. He has a strong record advising small and medium sized immunology biopharma companies in developing competitive therapeutic strategies and bringing new innovative molecules to the clinic.

Team Members

Jones w (woody) Bryan, ph.d.

Chief Business Officer

Jones (Woody) Bryan, Ph.D., brings almost 30 years of experience in the healthcare industry to the team, having led successful business development operations in both private and public pharma and biotech companies.

Team Members

Perry Calias, ph.d.

Chief Operating Officer

Perry Calias, Ph.D., brings over 25 years of experience in pre-clinical and clinical development, CMC and global regulatory submissions across the drug and device sectors of healthcare. He has held numerous executive positions leading clinical and non-clinical operations, with a strong focus on diseases of the central nervous system and rare diseases.

Team Members

Jonathan Rigby, mba

Group Chief Executive Officer

As employee #1 of Revolo Biotherapeutics in the US, Jonathan Rigby has led the company through substantial and rapid growth. He brings three decades of experience creating value and opportunities for companies in the pharmaceutical, biotech and drug delivery technology industry.

Team Members
  • Carrie Vincent: Director, HR & Senior Executive Administration
  • Dr. Jones W. (Woody) Bryan: Chief Business Officer
  • Dr. Roly Foulkes: Chief Scientific Officer
  • Jonathan Gold: Chief Financial Officer
  • Jeff Myers, MD: Chief Medical Officer
  • Marylyn Rigby: VP Marketing & Investor Relations
  • Dr. Perry Calias: Chief Operating Officer