Regulatory Affairs Specialists Job

REGULATORY AFFAIRS SPECIALISTS needed for a CONTRACT opportunity with Yoh's client located in BERKELEY, CA.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Minimum five (5) years of direct Regulatory Affairs CMC Biotech experience

WHAT YOU'LL BE DOING:

- The objective of this job is the identification of the current documentation in the Kogenate US BLA
- This will require revision of all documents submitted between 1998 and today to determine which one(s) are current.
- There are three sources for documents that will need to be compared and evaluated for their content and status.
- Candidate must be able to review all these documents and make a decision regarding path forward for them.

WHAT YOU NEED TO BRING TO THE TABLE:

- Experienced regulatory affairs CMC biotech professional- minimum five (5) years of direct Regulatory Affairs CMC Biotech experience
- Experience with US regulatory environment preferred
- Knowledge of biotech manufacturing required
- Detailed oriented
- Knowledge of excel, ease of use of different databases is required
- Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
- May compile and prepare materials for submission to regulatory agencies.

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- BS in Chemistry or related science degree required

RECRUITER:Mary Nguyen

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

J2W: PROF

TAX TERM: CON_W2

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