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CMC-Regulatory Affairs Program Manager (cGMP – Pharmaceutical) JD817707

JD817707

DPS Engineering is looking for an accomplished CMC Regulatory Consultant to support a biopharma client in the Boston, MA area. This individual will serve as the site leader for CMC regulatory strategy and products. This will include formulating and implementing global CMC regulatory strategies and leading CMC regulatory activities for the site.

Category:
Miscellaneous Personnel
Location:
Massachusetts
Years of Experience Req.:
7+
Date Posted:
15/06/2020
Days Remaining:
30
Employment Type:
Full-time
Education Level Req.:
Bachelors

Regulatory Affairs Consultant (cGMP – Pharmaceutical)  JD817707

Greater Boston, MA area

 

Summary:

 

DPS Engineering is looking for an accomplished CMC Regulatory Consultant to support a biopharma client in the Boston, MA area. This individual will serve as the site leader for CMC regulatory strategy and products. This will include formulating and implementing global CMC regulatory strategies and leading CMC regulatory activities for the site.

 

Job Responsibilities:

  • Interpret corporate policy, develop and implement CMC regulatory strategies for the earliest possible approval of regulatory submissions.
  • Plan and coordinate all site regulatory CMC activities.
  • Train technical personnel to write robust, efficient CMC sections for regulatory filings.
  • Write robust, efficient CMC sections, as required.
  • Main liaison with local FDA district office for inspections and local contacts.
  • Negotiate with external agencies (national and international) as needed to resolve key regulatory issues and expedite approvals of product and services.
  • Review and prepare urgent/timely responses to inquiries from global regulatory authorities relating to product registrations.
  • Direct communication with external regulatory personnel.
  • Communicate pertinent changes and updates to site staff and senior management.
  • Oversee the preparation and submission of applications and routine reports/renewals, including the preparation and submission of supplements and amendments as required by internal departments to update registered product information.
  • Evaluate site change controls, assess regulatory impact, and support their implementation.
  • Manage the appropriate periodic updates to the site master file, manufactures license, and associated documents.

 

Qualifications:

  • Minimum 7+ years of CMC regulatory experience within a biotech/pharmaceutical environment.
  • Prior experience and successful completion of BLA and/or NDAs and MAA application(s).
  • Direct experience interfacing with relevant regulatory authorities.
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
  • Ability to interpret compliance requirements for the creation or review of protocols and site documentation
  • Global CMC Regulatory experience highly desired: US, Canada, EU and Japan.
  • Demonstrated leadership capability and an ability to manage priorities and work under tight timelines.
  • Ability to establish priorities, work independently, and proceed with objectives without supervision.
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