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CMC Regulatory Affairs Project Manager Job

Company Name:
Arca24.com
Salary period: Annual
CMC Regulatory Affairs Project Manager needed for a contract opportunity with Yoh's client located in Collegeville, PA.
The Big Picture - Top Skills Should You Possess:
- CMC regulatory affairs
What You'll Be Doing:
- Global role for a highly motivated regulatory affairs professional, for 'small molecule' pharmaceuticals.
- Responsible for global Chemistry, Manufacturing, and Controls CMC regulatory activities for multiple projects/teams simultaneously and able to respond to changing events and priorities.
- Coordinate creation of CMC submission documents from early phase clinical submissions through to marketing applications and early life cycle activities.
- Work may be in cross-functional Matrix teams, including colleagues from regulatory, chemical and pharmaceutical development and manufacturing.
- Understand, interpret and advise on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new pharmaceutical products, to expedite submission, review and approval of global CMC applications.
- Maintain high quality standards.
What You Need to Bring to the Table:
- BSc in pharmacy, chemistry or related scientific discipline or equivalent.
- CMC regulatory affairs experience.
- Alternatively, chemical or pharmaceutical development experience gained with direct involvement in regulatory submission preparation for pharmaceuticals.
- Successful track record of delivering dossiers that comply with global regulatory requirements.
- Excellent team working abilities and effective influencing skills.
- Strong verbal and written communication skills with good attention to detail.
- Good time management skills with the ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
Opportunity is Calling, Apply Now!
Recruiter: Hannah Cihlar
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.
J2W: CLINICAL
MONJOB
J2WMIDATL
Ref:
SFSF: LS

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