Remote: Regulatory Operations Consultant (231457)

Life Sciences & Technology | Regulatory Affairs
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Job Description:

Our client is seeking  a Regulatory Affairs Operations Contractor/Manager for a 6+ month contract. This individual will provide regulatory support for the clinical development projects. This includes preparation and compilation of submissions for regulatory agencies; regulatory representative for assigned clinical studies; management of regulatory document preparation and timelines, and oversight of regulatory tracking tools, archives, and infrastructure, as assigned.

 

Responsibilities include:

  • As regulatory representative for assigned clinical studies, provides representation for study-level regulatory activities and updates in study team management meetings, supports clinical trial application activities, reviews and approves investigator essential document packages including FDA submissions, and manages other regulatory aspects of the study as directed.
  • Manages and tracks queries from and commitments to regulatory agencies, collaborates with subject matter experts to provide written responses to Health Authority queries, and provides periodic status updates regarding unfulfilled conditions/commitments.
  • Coordinates the authoring, review, and approval of Clinical, and Nonclinical documents for submission to Health Authorities (INDs, CTAs, amendments, annual reports, meeting packages, etc.)
  • Supports processes by which regulatory submissions are reviewed, finalized, and signed-off.
  • Participates in cross-functional sub-teams and working groups
  • Contributes to the development and maintenance of the Regulatory Affairs working practices and procedures
  • Maintains knowledge of global regulatory environment, regulations, and guidelines
  • Manages document archive processes.
  • Supports QC activities as needed
  • Provides support to senior Regulatory Affairs staff and management as needed

 

Required Experience:

  • Education: Minimum of a BA/BS degree in an appropriate scientific or other related field
  • 4+ years of relevant pharmaceutical industry, direct experience in regulatory affairs is preferred
  • Knowledgeable of international pharmaceutical guidance, regulations, drug development process, and industry standard practices

 

 

Remote: Regulatory Operations Consultant (231457)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
Remote

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