Manager, Regulatory Affairs: Job ID
Ascendis Pharma
- Palo Alto, CA
- $140,000-150,000 per year
- Permanent
- Full-time
- Responsible for strategic and operational regulatory input and support for cross functional (CMC, non-clinical and clinical) collaboration with other project team members.
- Contributes to the development of global clinical and regulatory plans and strategies, identifies, and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations.
- Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions and approvals associated with assigned projects
- Prepares and/or manages submissions that are technically complex and require extensive interaction with departments outside of regulatory affairs and external to the company.
- Maintains knowledge of highly complex regulatory requirements up to current date and communicates changes in regulatory information to project teams.
- Schedules and arranges own activities and those of direct reports.
- Work is performed under direction of a Senior Regulatory Affairs professional.
- BS/BA Degree in a Scientific Discipline, Advanced degree desirable.
- Minimum of 4 years of direct regulatory affairs experience in the biopharmaceutical industry.
- Effectively lead teams in preparation of investigational and marketed products submissions.
- Experience working on international teams desirable.
- Demonstrate solid 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.
- Review technical documents and influencing colleagues across functions.
- Must have experience in filing regulatory dossiers including CTAs, IMPDs, INDs required; experience with BLAs/NDAs/MAAs a plus.
- Ability to travel up to 10% of the time domestically and internationally.
- Salary range: $140-150K/year
- Medical insurance
- Vision insurance
- Dental insurance
- 401(k)
- Paid maternity leave
- Paid paternity leave
- Commuter benefits
- Disability insurance