DIRECTOR, CLINICAL REGULATORY AFFAIRS - WOMEN'S HEALTH

Brisbane, CA 94005

Posted: 06/25/2020 Job Category: Life Science Job Number: 2131

Job Description

Director, Clinical Regulatory Affairs, Women's Health

Industry: Biotech Pharma

Status: Full-Time Employee

Location: Brisbane, CA

 

THE ROLE YOU WILL PLAY

  • You will provide leadership on global regulatory activities and your responsibilities will include nonclinical, clinical and CMC regulatory filings and providing strategic as well as operational leadership on the project teams in these areas.
  • You will will develop regulatory strategies and manage IND and NDA submissions, FDA and other regulatory interactions, as well as international submissions, for the product candidates.
  • You must have the ability to work independently as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job.

COMPANY PROFILE

  • Our client is deeply invested in promoting health for millions of women and men, often in their most productive years, through science, medicine, and advocacy
  • Our client is a leader in the development of life-changing treatments for people with uterine fibroids, endometriosis, prostate cancer, and infertility
  • Our client is committed to working with scientific integrity in a collaborative, supportive and respectful manner while embracing challenge

FEATURES AND BENEFITS

  • Our client provides comprehensive benefits, including equity grants, 401(k) matching, FSA plan, and more
  • Supportive company culture that values the growth and empowerment of team members
  • Social hours, guest speakers, costume parties, onsite gym, free snacks, and more

BACKGROUND PROFILE

  • Advanced degree (MD, PharmD, or PhD) preferred 
  • 10 years of biopharmaceutical experience, which includes direct experience in Regulatory Affairs and proven experience successfully filing IND and NDA/MAA submissions
  • Approximately 10% travel

ABOUT ABA SEARCH
At ABA Search, we value professionalism, honesty, and hard work. We're positive, innovative thinkers, and we use creativity to turn challenges into opportunities. We thrive on deepening our expertise. We're energized by the biotech and pharmaceutical industries, passionate about staffing, and committed to the success of our clients and candidates. That's what makes us "the name to know in recruitment."

Check out the 2020 Forbes list of Best Recruiting Firms in America in both the Professional Recruiting and Executive Search categories!

Meet Your Recruiter

Josh Flagg
Executive Recruiter - Legal

Josh joined ABA in 2019 as a legal recruiter after relocating to the Bay Area from the East Coast. He worked as a legal recruiter for close to a decade in New York City focusing on lateral placements at international law firms with a special focus on Asia markets and practices. He holds a B.A. in Communications from Fordham University. He enjoys the excitement and challenges of getting to know and understand the personality and long-term goals of his clients in order to help them find success and professional fulfillment.

In another lifetime Josh was a professional musician who toured throughout the country, wrote jingles for commercials and started an independent concert promotion company. He lives outside San Francisco with his wife and daughter.

Favorite Things to Do in the Bay Area: Camping, hiking, and exploring new restaurants

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