- Responsible for strategic and operational regulatory input for cross functional (CMC, 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; influences global project teams and sub-teams
- Provides regulatory information and guidance for product development and planning throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure compliance and potential product expansion
- Acts as the company representative with regulatory authorities
- Prepares and/or manages submissions that are technically complex and able to have extensive/in-depth interactions with departments outside of regulatory affairs; ensures timely preparation of Health Authority submissions
- Excellent organizational skills (verbal and written) with 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
- 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 required.
- Minimum of 10 years overall regulatory experience (at least 6 years in Oncology), and preferably including experience managing investigational and marketed products
- 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
- Experience in filing regulatory dossiers including CTAs, IMPDs, INDs required; experience with BLAs/NDAs/MAAs is a plus
- Ability to travel up to 10-20% of the time domestically and internationally
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Director, Regulatory Affairs, Oncology - Palo Alto, California, United States - Ascendis Pharma
Description
The Director, Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines.
Provides expertise in translating regulatory requirements into practical, workable plans for project teams with international participants. May mentor and potentially supervise other regulatory professionals working on the project team and regulatory process-related topics. Requires ability to work strategically, both independently and in a team environment. The position will be based in Palo Alto, CA.Key Responsibilities
Requirements
A note to recruiters:
We do not allow external search party solicitation.
Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from:
Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.
Benefits
Medical insurance
Vision insurance
Dental insurance
401(k)
Paid maternity leave
Paid paternity leave
Commuter benefits
Disability insurance
Life Insurance (Basic, Voluntary & AD&D)
