18 days old

Director CMC Regulatory Affairs

Kelly Services
Thousand Oaks, CA 91358
**100% Remote***

Seeking a (Sr, Director, Associate Director, Sr Manager) of Regulatory Affairs, Chemistry, Manufacturing and Control (CMC) who is responsible for developing, leading and implementing global regulatory CMC strategies related to drug development (clinical trial applications), commercialization (marketing authorizations) and life cycle management of an expanding portfolio.

**Primary responsibilities of this position include:**

+ Provides strong regulatory and scientific leadership to the cross-functional development teams to ensure that the development plan provides for optimal scientific positioning, phase-appropriate quality assessments and highest regulatory probability of success.

+ Works collaboratively to address the regulatory elements associated with management of contract development and manufacturing organizations (CDMOs).

+ Leads the preparation, review and planning of CMC submissions to regulatory agencies including FDA, EMA, and other global Health Authorities to support the conduct of clinical trials and approval of marketing applications, and is responsible for the maintenance of these applications (INDs, CTAs, DMFs, BLAs, MAAs).

+ Ensures regulatory documents are developed with high quality, delivered in a timely manner, are consistent with corporate strategy and compliant with current global regulatory requirements.

+ Leads communication with Health Agencies on CMC issues

+ Facilitates preparation of briefing materials, responses to Health Authority questions, anticipates issues, and provides guidance to cross-functional teams on risk mitigation strategies with respect to CMC topics.

+ Works cross functionally to develop Regulatory submission plans and timelines.

+ Incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams

**Requirements Minimum:**

+ Bachelors degree Life/Health Sciences; Masters degree and/or Ph.D. preferred

+ Minimum 10 years of experience in pharmaceutical / biotech with minimum 6 years in CMC Regulatory Affairs

+ Experience negotiating CMC requirements with health agencies

+ Strong communication skills (written and oral) including presentation skills

+ Ability to work effectively and collaborate in a dynamic environment with a diverse team of co-workers

**Recommended Experience and Knowledge**

+ Thorough knowledge of US and international regulations as they apply to CMC aspects of drug, biologic, ADC, and nanoparticle development, including understanding of expedited approval pathways

+ Demonstrated experience managing development of INDs and global clinical trial applications and well as BLAs/MAAs.

+ Considerable experience leading or preparing for regulatory agency interactions on complex CMC topics (FDA meetings, EMA Scientific Advice, Advisory Committees, Oral Explanations, etc.)

+ Strong technical and analytical skills with ability to make data-driven decisions

For immediate consideration, email resume directly to the recruiter:


**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (


Posted: 2021-09-01 Expires: 2021-10-02

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Director CMC Regulatory Affairs

Kelly Services
Thousand Oaks, CA 91358

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