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Associate Director, Regulatory Affairs – Oncology

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Company :
Ascendis Pharma

Location :
Palo Alto, California

Expiry Date :
Sat, 06 Feb 2021 23:59:59 GMT

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Description :
The Associate Director, Regulatory Affairs, Oncology will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. Ensures timely preparation of organized and scientifically valid submissions involving our oncology programs. 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 both independently and in a team environment. The position will be based in Redwood City, CA and reports directly to the Senior Director, Regulatory Affairs.

Key Responsibilities

* Responsible for strategic and operational regulatory input for cross functional (CMC, non-clinical and clinical) areas in collaboration with other project team members, including CMC regulatory 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.
* Prepares and/or manages submissions that are technically complex and require extensive interaction with departments outside of regulatory affairs.
* 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.

Requirements

* BS/BA degree is required, an advanced degree is a plus
* Minimum of 8 years of drug development experience (minimum 6 years in regulatory affairs) in the biopharmaceutical industry.
* Effectively lead teams in preparation of investigational and marketed products submissions.
* Experience working on international teams desirable
* Demonstrate 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.
* Review complex 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 10-20% of the time domestically and internationally.

Benefits

* Medical insurance
* Vision insurance
* Dental insurance
* 401(k)
* Paid maternity leave
* Paid paternity leave
* Commuter benefits
* Disability insurance

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