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1+ months

Sr. Director, CMC Global Regulatory Affairs

Kelly Services
Cleveland, OH 44101
**Kelly Services is actively recruiting for a Sr. Director, CMC Global Regulatory Affairs (must have Cell Therapy experience) for a Direct Hire opportunity in Cleveland, OH.**


WE ARE SEEKING: A Senior Director, CMC Global Regulatory Affairs to provide regulatory leadership, operational and Strategic oversight to cross functional teams in developing global Regulatory CMC activities and executing submissions related to biologics with preferred experience with cell therapy products, reporting into Senior Vice President of Global Regulatory Affairs.


Summary:

Maintain timelines in cooperation with project management, cross-functional teams, and Regulatory Operations to ensure on-time regulatory submissions.

Assist with the planning, scientific writing and performance of critical reviews of quality related sections of pre-INDs, INDs, IMPDs, BLAs, MAAs, annual reports, DSUR, amendments, amendments, and supplements to ensure a high-quality regulatory submission and approval.

Ensure that all regulatory submissions are of highest regulatory standards.

Coordinate and manage regulatory inspections, as needed, at the manufacturing vendors sites or if the inspection relates to regulatory CMC issues.

Assist in review of manufacturing change controls by cross-checking the description in regulatory filings in INDs/IMPDs, CTAs and BLAs/MAAs and to ensure that CMC related changes are reported to competent authorities in accordance with regulatory requirements.

Support establishing, managing, and maintaining a knowledge base of current and emerging

regulatory requirements and guidelines in the CMC field.

Assist in tracking of CMC regulatory commitments for INDs / IMPDs, CTAs and BLAs / MAAs.

Participate, as needed, in planning, organizing, and managing the CMC component of pre-IND, pre-BLA and other regulatory meetings with the FDA / EMA / PMDA, etc.

Participate in CMC project team meetings and provide current regulatory requirements that pertain to stability studies and analytical characterization tests.

Develop CMC regulatory strategy and manage regulatory activities and timelines for investigational and marketed products.

Lead the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies.

Review and approve technical documentation including technology transfer protocols, validation protocols, technical reports, manufacturing, and labeling information to ensure conformance with regulations and existing regulatory approvals.

Provide CMC regulatory guidance to project teams.


Knowledge/Skills

Strong experience in Regulatory CMC with strong technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).

Strong experience in biologics (preferably cell therapy).

Demonstrated ability to develop creative and out of the box thinking approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events. Depth of experience in defining global Regulatory CMC strategy, superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities, and works well under pressure.

Excellent interpersonal, verbal and written communication, presentation, and listening skills with a proven record of working with, and influencing, multi-disciplinary teams and external experts.


Education/Experience

M.S./ PhD in biochemistry, biology pharmacy, chemistry, engineering or a related discipline.

Minimum of 20 years experience in pharmaceutical product development with a minimum of 10 years in leadership CMC regulatory affairs and a strong biologics background

At least 1 successful BLA/MAA (biologics) filing required

Cell therapy / Regenerative Medicine experience preferred


**If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.**


**_\#TJP2022_SPEC_**


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-04-18 Expires: 2022-06-18

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Sr. Director, CMC Global Regulatory Affairs

Kelly Services
Cleveland, OH 44101

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