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Sr. Drug Safety Associate - Regulatory CMC

  • Tech Observer
  • 01/10/19
  • Westborough, MA
  • 01581
  • TBD / Hourly
  • Contractor
Long-term W2 Contract Opportunity with direct PHARMACEUTICAL client based in Westborough, MA - Massachusetts

Ideal Candidate will have at least a Bachelor's degree in Life Sciences or Engineering in addition to 10 years of industry experience in regulatory, manufacturing, technical development, or QA/ QC
Regulatory CMC is REQUIRED
Strong understanding of Manufacturing Process is REQUIRED

Responsibilities and Duties:
Independently provides project team representation while working closely with Manufacturing, Quality, Technical Support/service groups and Site Senior management to compile the required information in accordance with established timelines
Monitors and tracks information, assuring accurate communication of the current status of post-approval change control assessments and submissions
Coordinates and prepares regulatory document packages to support post-market changes.
Provides project team representation, consults on regulatory project needs and is responsible for developing required regulatory documentation/submissions.
Provides direction in managing information from/to other departments.
Reviews technical documentation (Project Plans, Change Control, Deviations, CAPA, Batch Records)
Recommends/approves changes for manufacturing and compliance, ensuring conformance with existing regulatory approvals
Responsible for determining if changes and deviations are in compliance with regulatory licenses (in all applicable countries) for the commercial products.
Ensure products manufactured and tested at manufacturing sites adhere to the regulatory licenses.
Provide regulatory guidance and strategy Responsible for drafting and finalizing CMC submission with Regulatory Affairs / RA-CMC product lead

Qualifications and Skills:

Bachelors or Master's degree in the Life Sciences or Engineering and at least 10 years of experience in regulatory, manufacturing, technical development or QA/QC
In-depth knowledge of regulatory requirements for biopharmaceutical development and manufacturing.

Preferred Qualifications:
BS, MS or PhD in Biology, Chemistry, Engineering or related field.
Solid understanding of GMPs, FDA regulations and ICH guidance pertaining to drug and/or biologic regulations.
Strong understanding of manufacturing processes
Have direct hands-on experience with post-marketing regulatory activities (i.e. AR, CBE-30, Client, Variations) for biologic and/or drug products
Ability to effectively interpret guidance and provide recommendation to key stakeholders
Regulatory, Manufacturing, QA/QC experience
Proficient in MS Word, Excel, PowerPoint, MS Project, and TrackWise.

Employer Information

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