Senior Director, Regulatory Affairs
AN2 Therapeutics (AN2) is a biopharmaceutical company focused on developing novel medicines for patients with rare, orphan infectious diseases that represent significant unmet needs. 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 Senior Director 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 while maintaining a collaborative relationship through effective communications with FDA and other health authorities. In addition, this person will have oversight of Regulatory compliance during clinical trial conduct, including collaborating with the Clinical Development team on the development, implementation and oversight of GCP Quality Affairs. This position may have formal oversight of Regulatory Operations and Document Control team members and/or consultants. This position will report to the VP of Clinical Sciences and Development Operations.
Lead efforts to develop IND submission for AN2 Therapeutics’ lead drug product, as well as other pipeline candidates.
Provide regulatory guidance to company personnel in preparation for the IND and key regulatory documents for AN2 Therapeutics drug products and be responsible for ensuring that all state and federal regulatory requirements are met.
Represent regulatory affairs during FDA discussions and actively participate and analyze regulatory correspondence. Coordinates follow-up discussion with internal colleagues and external parties to ensure all regulatory requests and commitments are met with accuracy and in a timely fashion.
Identify and assess regulatory risks associated with CMC and Clinical sections of the IND. Define strategies to mitigate those risks and works with the teams to implement them.
Provide Regulatory expertise to ensure that clinical trial operations are conducted in accordance with company SOPs, FDA regulations, and ICH guidances, including Adverse Event reporting, Clinical Trial Material (CTM) labeling, etc.
Direct the organization and preparation of complete and effective submissions for all AN2 Therapeutics drug products.
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.
Form informal networks with functional leaders to discuss regulatory developments.
Ensure that the interfaces between Regulatory Affairs and other departments are managed optimally.
Ensure effective team communication throughout the Regulatory and Quality department and provide coaching to the Regulatory Affairs group in various aspects of Regulatory sciences.
Qualifications and Experience
B.S. in life sciences required, advanced degree in a relevant discipline preferred
Proven knowledge and experience in the preparation of major regulatory submissions (INDs, NDAs, CTAs) 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 experience in preparation of market applications for major markets (i.e., EU, Canada, Japan)
Demonstrated ability to effectively participate in meetings with Regulatory agencies
Ability to foster effective, positive interactions with Regulators
Ability to lead and influence project teams, committees, etc. to attain group goals through excellent leadership and people management skills
Strong interpersonal skills and ability to collaborate effectively with a variety of personnel including medical, scientific, and manufacturing staff in a multicultural/multinational environment
Highly organized, detail oriented, effective written and oral communication skills
Highly proficient in the use of Word, Excel and Power Point
Prior supervisory experience is desirable
Experience in Infectious Disease and/or Pulmonary Medicine is highly desirable
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 and include the job title and number in the subject.
Job Reference Number: RA-1004
* AN2 Therapeutics is based in Menlo Park, CA, but employees are currently working remotely due to the COVID-19 pandemic.