Are you actively seeking for a new SENIOR REGULATORY CMC PROJECT MANAGERrole in SUMMIT, NEW JERSEY area* I have a CONTRACT opportunity with an American biotechnology company that discovers, develops and commercializes medicines for cancer and inflammatory disorders. If you meet the requirements, please send me your updated resume to Kelly.Hua@Yoh.Com. "YOU MUST BE ELIGIBLE TO WORK IN THE US WITHOUT SPONSORSHIP."

RESPONSIBILITIES WILL INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING:

* Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings. * Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision. * Responsible for the global regulatory evaluation of CMC change controls with supervision. * Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision. * Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams. * Participate in global regulatory interactions with health authorities, with supervision. * Facilitate document review meetings and discussions. * Develop and maintain knowledge of regulatory environment, regulations and procedures.

SKILLS/KNOWLEDGE REQUIRED:

* Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents) * Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations * Experience in drug development processes and post-approval requirements * Experience in developing CMC regulatory strategy * Experience in project management Have a solution-oriented approach to problem solving * Ability to plan/prioritize work of group members and guide/develop others. * Ability to work on complex projects and within cross-functional teams with supervision * Excellent communication skills, both written and oral

Opportunity is Calling, Apply Now!

Recruiter: Kelly Hua

Kelly.Hua@yoh.com

What's In It For You*

We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.

* Medical, Dental & Vision Benefits

* 401K Retirement Saving Plan

* Life & Disability Insurance

* Direct Deposit & weekly ePayroll

* Employee Discount Programs

* Referral Bonus Programs

Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here!

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here:
http://www.yoh.com/applicants-with-disabilities
to contact us if you are an individual with a disability and require accommodation in the application process.