Senior Associate, Regulatory Affairs
Senior Associate, Regulatory Affairs
About Audentes Therapeutics
Audentes Therapeutics is a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases. We are leveraging our AAV gene therapy technology platform and proprietary manufacturing expertise to develop programs across three modalities: gene replacement, vectorized exon skipping, and vectorized RNA knockdown. Our product candidates are showing promising therapeutic profiles in clinical and preclinical studies across a range of neuromuscular diseases. Audentes is a focused, experienced and passionate team driven by the goal of improving the lives of patients.
Audentes takes pride in strong, global relationships with the patient, research, and medical communities, and we take equal pride in carefully selecting our colleagues. If you believe you match what we're looking for, we'd love to hear from you. Our compensation philosophy embodies what you'd expect from an innovative life sciences employer competing for the best talent available.
Listed below is a current opening for which we are seeking smart, driven, experienced, and just plain nice people to join us in realizing Audentes' mission.
The Senior Associate, Regulatory Affairs will focus on clinical and nonclinical aspects of domestic and international regulatory affairs for clinical development program. Support interactions with global health authorities, and corporate partners with regulatory deliverables. Continues to expand knowledge base of laws, regulations, and guidelines governing the development, licensure, and marketing of biologic products. The Senior Associate will be located in our San Francisco office.
The specific responsibilities of this position include:
- Coordinate the preparation, submission, management and maintenance of domestic and international regulatory submissions related to clinical and nonclinical aspects of product development, including the following: INDs/CTAs, amendments and information requests; Marketing Applications (MAs) in the US and globally, including amendments/supplements; Orphan drug applications; and Annual Reports.
- Assist in coordination and preparation for Agency meetings and associated briefing document preparation
- Participate/facilitate relevant functional area and project team meetings, including development and study specific sub teams
- Review documents (SOPs, protocols, ICFs and reports) related to clinical or nonclinical studies as necessary
- Exercise discretion and independent judgment in the performance of the duties described above
Required Education, Skills and Experience
- BA/BS degree in life sciences with 3+ years' industry experience as a Regulatory Affairs Associate in the pharmaceutical or biotechnology industry with a clinical and nonclinical emphasis
- Skilled at gathering regulatory information and developing product approval strategies
- Proven track record of managing critical projects as a part of an interdisciplinary team
- Demonstrated experience working on regulatory submissions to deadlines
- Thorough understanding of relevant drug development regulations and guidelines
- Excellent organizational, interpersonal and communication skills, oral and written
- Strong attention to detail, excellent organizational skills
- Strong computer skills including MS Office (Word, Excel, Outlook)
- Commitment to Audentes values: Be BOLD, Care deeply, #GSD
Preferred Education, Skills and Experience
- Advanced degree
- Rare disease and/or cell or gene therapy experience
|Posted on||23 Mar 2019|
|Career level||Experienced (non-management)|
|More details (document)|