Associate Director, Regulatory Affairs
Ascendis Pharma, United States

Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
No
Qualification
As mentioned in job details
Total Vacancies
1 Job
Posted on
May 3, 2021
Last Date
Jun 3, 2021
Location(s)

Job 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 Palo Alto, CA and reports directly to the Senior Director, Regulatory Affairs, Oncology.

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, 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 in a scientific discipline; advanced degree desirable.
  • Minimum of 10 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.
  • Demonstrate extensive knowledge of regulatory requirements, including ICH and regional requirements, and 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.
  • Experience working on international teams desirable.
  • Must have experience in filing regulatory dossiers including CTAs, IMPDs, INDs required; experience with BLAs/NDAs/MAAs a plus.
  • Ability to travel up to 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

Job Specification

Job Rewards and Benefits

Ascendis Pharma

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