Director, Regulatory CMC
San Diego, CA 92121
Director, Regulatory CMC
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.
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
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