Yoh, A Day & Zimmermann Company

5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience.. 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..  Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents).  Experience in developing CMC regulatory strategy

regulatory

Global Regulatory CMC Manager - Summit or Lawrenceville, NJ - ONSITE 9 month contract W2 Pay rate:  $84.00 - $87.00/hr PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience. Experience with sterile products preferred. Responsibilities will include, but are not limited to, the following: 1. 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. 2. 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. 3. Responsible for the global regulatory evaluation of CMC change controls with supervision. 4. Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision. 5. Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams. 6. Participate in global regulatory interactions with health authorities, with supervision. 7. Facilitate document review meetings and discussions. 8. 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! 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. <ul><li>Medical, Dental & Vision Benefits</li><li>401K Retirement Saving Plan</li><li>Life & Disability Insurance</li><li>Direct Deposit & weekly ePayroll</li><li>Employee Discount Programs</li><li>Referral Bonus Programs</li></ul> 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!  Note: Any pay ranges displayed are estimations.  Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description.  All qualified applicants are welcome to apply. Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

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