Director, Regulatory CMC

San Diego, CA 92121

Posted: 04/12/2022 Job Category: Pharma / Biotech Job Number: 2553

Job Description

Director, Regulatory CMC

Industry: Biopharmaceutical

Status: Full-Time Employee

Location: Remote - OR Hybrid onsite (San Diego, CA)

 

THE ROLE YOU WILL PLAY

  • Responsible for compilation and submission of high-quality CMC related sections of INDs/CTAs/NDAs/MAAs.
  • Maintain responsibility for CMC Regulatory timelines.
  • Lead negotiations with regulatory agencies to resolve CMC issues and oversee proactive interactions with regulators globally.
  • Assist in the development and maintenance of Regulatory SOPs.
  • Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.

COMPANY PROFILE AND BENEFITS

  • Small global biopharmaceutical (sponsor) company (100+ employees)
  • Our client is passionate about developing novel drug therapies to improve people’s lives and overall health in the areas of Endocrine and Rare Disease.
  • Flexible time off policy and holiday shutdown periods.
  • Work/Life balance with well supported teams
  • Exceptional compensation and benefits package including stock options, 401K matching, PTO, health benefits, and vacation time.

BACKGROUND PROFILE

  • MS or PhD with at least 10 years of regulatory experience and a minimum of 7 years regulatory CMC experience.
  • Knowledge of foreign and domestic regulations pertaining to the development, manufacturing, and distribution of investigation.
  • Experience with electronic document control and management systems.
  • Considerable experience with development of CMC development, process validation, comparability protocols, amendments, and supplements.
  • Effective written and verbal communication skills with the ability to inspire and influence at all levels.

 

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 life science 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."

 

Meet Your Recruiter

Denise Levine
Director, Executive Search - Biometrics

Denise joined ABA in 2019, as a Director of Executive Search. She has been working as a Recruiter for the past 16 years, 10 of which have been supporting the Biotechnology and Pharmaceutical industries, specifically in the areas of biometrics and clinical trials. She holds a Bachelor of Arts degree in Psychology from Emmanuel College in Boston, MA. Denise takes pride in developing long-term relationships and is particularly excited about getting to know clients and candidates beyond the job description and the resume. She is passionate about connecting top talent with the right opportunity. 

Born and raised in the San Francisco Bay Area, Denise played soccer throughout her youth and also in college. She's currently the Assistant Coach to her son's soccer team. Denise lives in Placer County where she enjoys family time with her husband, two boys, and their chocolate lab, Suzy. She spends her weekends on house projects, gardening, crafting, coaching her son’s soccer team, exploring, spending time with friends and family, and camping.

Favorite things to do in Placer County: Exploring all of the fun activities Placer County has to offer, lake days, and wine tasting

Favorite Quote: "Keep your face always toward the sunshine and shadows will fall behind you." – Walt Whitman

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