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.
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.
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.