The project initially in scope for the position is within endocrinology and has reached late-stage development.
You will be responsible for developing and implementing global regulatory strategies encompassing clinical and non-clinical disciplines, and
- Working closely with RA CMC, device, and other regulatory functions
- Manage regulatory aspects of compounds through all phases of development, post-approval, and life cycle management, with initial focus on NDA submission.
- Ensure timely preparation of organized and scientifically valid submissions.
- Provide expertise in translating regulatory requirements into practical, workable plans for project teams with international participants.
The position requires ability to work both independently and in a team environment.
The position will be based in Palo Alto, USA.
Key Responsibilities
- Responsible for strategic and operational regulatory input for cross functional (non-clinical and clinical) areas in collaboration with other project team members and regulatory colleagues.
- Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations.
- Planning and coordinating regulatory submissions necessary to support all types of regulatory applications, e.g. clinical trial applications, marketing authorizations, variations/post-approval changes ensuring efficient regulatory interactions with health authorities. The initial focus and priority will be the NDA preparation and submission.
- Acts as the company representative with FDA.
- Contributes to development of global labeling documents (prescribing information and patient information), with specific focus on US label.
- Prepares and/or manages submissions that are technically complex and require extensive interaction with departments outside of regulatory affairs.
- Excellent organizational skills and ability to work on and/or oversee a number of projects with tight timelines.
- Maintains up-to-date knowledge of highly complex regulatory requirements and communicates changes in regulatory information to project teams.
Estimated Compensation 175-200K/year DOE
Requirements
- BS/BA Degree in a Scientific Discipline required, Advanced Degree preferred
- Minimum of 8 years overall regulatory experience, and preferably including experience across the life cycle of pharmaceutical products and across main regions such as US, EU, Japan and Canada.
- Experience in filing regulatory dossiers including CTAs/IMPDs/INDs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, and developing and implementing regulatory strategies.
- Prior experience representing Regulatory Affairs on cross-functional teams is desirable. Must be capable of effectively leading teams in preparation of submissions.
- Experience working on international teams desirable.
- Must have an extensive knowledge of regulatory requirements, including ICH and regional requirements, and have an understanding of current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business.
- Must be capable of critically reviewing complex technical documents and influencing colleagues across functions.
- Experience with drug-device combination products preferred, but not required.
- Travelling is estimated to 10-15 days per year.
Benefits
- Medical insurance
- Vision insurance
- Dental insurance
- 401(k)
- Paid maternity leave
- Paid paternity leave
- Commuter benefits
- Disability insurance