Regulatory Associate Job

REGULATORY ASSOCIATE needed for a CONTRACT opportunity with Yoh's client located in Research Triangle Park, NC.

TOP SKILLS SHOULD YOU POSSESS:

- Regulatory Affairs
- CMC

WHAT YOU'LL BE DOING:

- Preparation of high quality, detailed CMC regulatory documents using varied information sources.
- Responsible for liaising closely with other personnel or 3rd party groups to ensure accuracy of such records.
- Responsible for working to agreed timelines and for highlighting potential delaying factors promptly to line management.
- Responsible for assessing regulatory impact of change controls/requests for marketed products.

WHAT YOU NEED TO BRING TO THE TABLE:

- Chemistry, pharmacy, or closely related science Bachelor's Degree
- Knowledge of drug development and manufacturing and supply processes.
- Knowledge of CMC regulatory and/or Quality requirements
- CMC regulatory affairs or product development experience gained with involvement in regulatory submission preparation.
- Ability to interpret, draw conclusions, and present data in a clear concise manner.
- Verbal and written communication skills and team working abilities.
- Proven technical writing skills.
- Ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
- Computer skills in Microsoft Office applications with the ability to learn new applications quickly.
- Easily motivated, detail-oriented, excellent time management skills, influencing skills

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- Three to five (3-5) years of Pharmaceutical Industry experience.
- CMC regulatory affairs experience with a track record of delivering dossiers that comply with global regulatory requirements.
- Significant project management skills by handling diverse projects and activities at different stages of criticality at any one time
- Excellent oral and written communication skills including the preparation of submissions.
- Ability to multi-task and develop timelines for deliverables.
- Knowledge and/or experience of pharmaceutical development, manufacturing and quality control for active pharmaceutical ingredients and/or drug products.
- Demonstrated ability to handle complex CMC issues
- Demonstrated ability to build and maintain effective networks
- Preferably experience of North American, European and/or International markets

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

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