Senior Director, Regulatory Affairs (RA-1045)
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 and hands-on Senior Director, Regulatory Affairs to represent the function on cross-functional teams while providing regulatory expertise as well as strategic and operational guidance throughout the drug development process. The Senior Director should be able to work largely independently in a US or Global Lead role for a study or program. The person in this role will initially be focused on clinical regulatory strategy and execution and ultimately be responsible for successful organization, preparation, and submission of Regulatory filings while maintaining a collaborative relationship through effective communications with internal stakeholders, FDA, PMDA, and other Health Authorities. This position will report to the SVP of Regulatory Affairs and Quality Assurance.
- Lead the development of regulatory documents (eg, meeting requests and briefing documents; responses to Health Authority queries; PSPs/PIPs) and IND/CTA and NDA/JNDA/MAA submissions for AN2’s drug products. Participate in review of all documents with a regulatory component or for submission to Health Authorities (eg, protocols, IBs, DSURs, CSRs, SOPs).
- Provide regulatory expertise and guidance to company personnel and be responsible for ensuring that clinical trials are conducted in accordance with company SOPs, as well as ICH, FDA, and other relevant regulations and guidance.
- Support the SVP of Regulatory Affairs during in FDA and other Health Authority interactions. Accountable to analyze, understand, track, and manage regulatory correspondence and commitments for assigned projects or programs.
- Identify and assess regulatory risks, define strategies to mitigate those risks, and work with the teams to implement risk mitigations, including adapting strategies to evolving regulations and Health Authority feedback.
- Provide regulatory leadership and expert guidance on core project teams and subteams. Prepare and deliver effective presentations for external and internal audiences as needed.
- Ensure effective inter-departmental and team communication and mentor or coach colleagues on various aspects of Regulatory sciences. Form informal networks with functional leaders to discuss regulatory developments.
Qualifications and Experience:
- B.S. in a relevant discipline is required, an advanced degree is preferred
- Proven knowledge of and experience in the preparation of major regulatory submissions (INDs, CTAs, NDAs, JNDAs, MAAs) and amendments
- At least 10 years of regulatory experience and a strong understanding of US and outside of the US regulations and review processes
- Prior experience in interacting with and preparation of marketing applications for PMDA, EMA, and other Health Authorities preferred
- Demonstrated ability to effectively participate in meetings with Health Authorities
- Ability to foster effective, positive interactions with Health Authorities
- Experience with infectious diseases, global health, orphan drugs, or expedited development designations and pathways is highly desirable
- Experience with small molecules is strongly preferred
- Project Management or prior US or Global Lead experience is desirable
- Ability to lead and influence project teams, committees, etc. to attain group goals through excellent leadership and people management skills
- Highly organized, detail oriented, effective written and oral communication skills
- Highly proficient in the use of MS Word, Project, and Power Point
- Ability and commitment to work on site and travel as business needs demand
- Prior supervisory experience is desirable
AN2 anticipates that the annual base salary for this position could range from between $275,000 to $280,000 and will depend, in part, on the successful candidate’s credentials for the role, including education, qualifications, and type as well as length of experience. Any offered salary is also based on internal equity, internal salary ranges, market data, and the position’s wage range. Compensation decisions are dependent on the facts and circumstances of each case. The successful candidate will also be eligible to participate in a performance-based bonus and stock programs, various benefits offerings, including, but not limited to, medical, dental and vision insurance, disability, life insurance, 401k retirement savings plan, and flexible paid vacation.
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.
Our open positions are managed through our Human Resources department. Unsolicited resumes from recruiting agencies, in advance of a specified agreement, will not be accepted. Resumes sent directly to our employees or our consultants from recruiting organizations will also not be accepted as referrals and do not obligate us to pay fees.
Please send your resume to careers@AN2Therapeutics.com and include the job title and RA-1045 number in the subject.