Location: New York, NY
Sr. / Manager, Regulatory Affairs
Axsome Therapeutics is currently searching for a (Sr.) Manager, Regulatory Affairs to lead our regulatory affairs efforts. We are a biopharmaceutical company developing novel therapies for the treatment of CNS disorders. By focusing on this therapeutic area, Axsome is addressing growing markets where current treatment options are limited or inadequate. Axsome has a broad portfolio of clinical development stage as well as research stage products. Axsome is located in New York City, New York.
The role is responsible for assuring the successful planning and completion of regulatory activities on a worldwide basis supporting the development and commercialization of Axsome’s product candidates. This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by the program director when needed. The Manager is responsible for mentoring associates as appropriate.
- Provide strategic guidance on FDA and global regulatory requirements for clinical development and registration of small molecule pharmaceuticals.
- Oversee interactions, and acts as primary contact, with regulatory agencies.
- Lead preparations for agency meetings, communications, and submissions.
- Oversee all regulatory submissions including NDA, MAA, IND, TGA, and CTA filings.
- Compile, review, and approve modules of development and marketing registration applications, amendments, and supplements for submission.
- Oversee development and implementation of regulatory strategies for the earliest possible product approval.
- Develop and write regulatory designation requests (e.g. Fast Track and Breakthrough Therapy Designation requests) as well as general regulatory communications and submissions.
- Ensures the company is compliant with US and international regulatory requirements. Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
- Assess compliance risk areas (internal and external) and develop and implement risk mitigation measures.
- Assist and provide guidance for regulatory inspection readiness activities.
- Provides analysis of regulatory guidance documents and regulations to management team.
- Create, manage, measure, and report timelines for milestone deliverables.
- Participate in the development, review, and implementation of departmental SOPs, initiatives and processes.
- Perform other work related duties as assigned.
- Bachelor degree required. Preference to candidates with a scientific background (RN, MS, PhD or similar).
- Proficiency in FDA electronic gateway submissions.
- Broad understanding of eCTD requirements.
- Preference to candidates with prior small company experience.
- Preference to candidates with prior NDA and MAA filing experience.
- Preference to candidates with prior CNS experience.
- Knowledge of the 505(b)(2) regulatory strategy.
- Must be able to work in the NYC office.
- Established knowledge of regulatory guidelines and regulations (US and international).
- Regulatory experience supporting both development projects and marketed products preferred.
- Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, is preferred.
- Ability to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies lead to obtaining results.
- Strong attention to detail and excellent organization skills.
- Exceptional communication skills (written and verbal) as evidenced by a demonstrated ability to prepare complex documents and submissions and to give presentations.
- Strong interpersonal skills.
- Ability to problem solve, delegate appropriate tasks and/or develop junior team members.
- Excellent sense of urgency to deliver at/surpass study conduct targets.
- Strong leadership skills, self-motivated, adaptable to a dynamic environment.
- Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities.
- Preference to energetic candidates with a desire to think “outside the box”.
- Willingness to travel periodically as needed.