Director, Regulatory Affairs
AN2 Therapeutics, Inc. (AN2) is a biopharmaceutical company focused on developing novel anti-infective medicines for patients with rare, chronic infectious diseases – including global and neglected tropical diseases – that have significant unmet medical needs for new therapies. Founded by a team of experienced industry leaders in infectious diseases drug research and development, we strive to provide patients with treatments that will restore their health and enable them to live productive lives. AN2 is a mission-driven company with a passion for improving global public health and a vision to accelerate development of novel medicines to treat serious infectious diseases and save lives worldwide. We believe our company thrives when all employees share this mission.
AN2 is seeking an experienced regulatory affairs director with the ability to work with limited direction and oversight to be responsible for providing regulatory strategy, expertise, and operational guidance to cross functional teams throughout the drug development process. The position will be ultimately responsible for successful organization, preparation, and submission of regulatory filings including meeting requests, briefing documents, and INDs/CTAs/CTNs while maintaining a collaborative relationship through effective communications with FDA, EMA, PMDA, and other health authorities. This position may have oversight of regulatory vendors and/or consultants in one or more regions. This position will report to the SVP of Regulatory Affairs and Quality.Responsibilities:
- Lead efforts to prepare for, execute, and/or maintain an IND(s) and CTAs/CTNs for the AN2 Therapeutics lead drug product, as well as other pipeline candidates. Ensure that all relevant regional regulatory requirements are met.
- Represent regulatory affairs during FDA, EMA, PMDA, or other health authority discussions; author, manage, and/or review meeting materials (meeting requests, briefing documents, responses to comments, minutes).
- Actively participate in and analyze regulatory correspondence; coordinate discussions with internal colleagues and external parties to ensure all regulatory requests are understood and commitments are met with accuracy, attention to quality, and in a timely fashion.
- Identify and assess regulatory gaps and risks associated with CMC, Nonclinical, and Clinical programs on an ongoing basis, in a phase-appropriate manner. Define strategies to mitigate those risks and works with the teams to implement them.
- Ensure that all adverse events are dealt with in accordance with company SOPs and FDA or other applicable regional regulations and ICH guidances.
- Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development. Prepare and deliver effective presentations for external and internal audiences as needed.
- Ensure that the interfaces between Regulatory and other departments are managed optimally.
- Develop strategic and operational plans that ensure corporate goals and program timelines are met, in collaboration with management and the cross-functional team.
- Participate in the review of documents for regulatory submission and study start-up and maintenance such as protocols, ICFs, IBs, IMPDs, study plans, CSRs, DSURs, etc. to ensure they are compliant with relevant regulations and guidance (eg, ICH, FDA, EMA, etc.) prior to submission or implementation.
- Ensure effective team communication throughout the Regulatory and Quality department and provide coaching to the regulatory group in various aspects of regulatory sciences.
- B.S. in life sciences.
- Proven knowledge and experience in the preparation of major regulatory submissions (INDs/CTAs/CTNs and NDAs/MAAs/JNDAs) and amendments for New Molecular Entities (NMEs).
- At least 10 years of regulatory experience and a strong understanding of US regulations and FDA review processes.
- Prior knowledge and experience on US NDA preparation and submission using eCTD format and applicable tools. Experience in preparation of market applications for major markets (ie, EU, Canada, Japan) is strongly preferred.
- Ability to foster effective, positive interactions with regulatory agencies.
- Ability to lead and influence project teams, committees, etc., to attain group goals.
- Demonstrate excellent leadership and people management skills.
- Strong interpersonal skills and ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff in a multicultural/multinational environment.
- Aligned to the company core values of passion, teamwork, integrity, and constant improvement
- Highly organized, detail oriented, effective written and oral communication skills, including a high level of proficiency in the use of Word, Excel, Power Point, and SharePoint.
- Prior supervisory experience is desirable.
- Experience in the Infectious Disease therapeutic area highly desirable.
- Maintain current knowledge of the applicable US and global regulations, guidance, and standards for drug development and product registration.
By joining our small, highly-dedicated and motivated team, you will experience a culture that is inclusive, supportive, and humble, yet challenging. We set our egos aside to collaborate for the benefit of the team, and most importantly, the patients in need of new therapeutic options. AN2 is a company with a passion for improving global public health. We approach our business using a double bottom line strategy — with the intention of a fiscal and social return — this is reflected in our Core Values and is the foundation of our company’s culture. We employ the industry’s best to create a corporate culture that is fun, humble, respectful, and fulfilling, and where employees feel that they are making a difference and feel inspired to bring their passion to work.
We are an equal opportunity employer that values diversity, equity, and inclusion. We consider all qualified applicants regardless of race, sex, gender identity or expression, sexual orientation, age, religion, national origin, marital status, veteran status, or ability status. We will ensure that individuals who are differently abled are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment as provided to other applicants or employees. Please contact us to request accommodation.