Regulatory Manager

Regulatory Manager
  • $111.56 per Hour
  • Temporary
  • Durham NC, US Durham DURHAM US
Job Ref: JO000129785
Sector: Clinical
Sub-sector: Reg & Compliance
Date Added: 14 April 2022

Job Title: Regulatory Manager

1 year - Renewable Contract or potential for conversion

Onsite training and excellent benefits.


Location: Remote


Key Responsibilities
• Support BLA/MAA/ROW (emerging markets) expansion effort for a biologics project, including compilation of market-specific requirements and leading information request response preparation
• Track submission activities and change controls for RACMC and ensure visibility to cross-functional CMC stakeholders
• Assist with ongoing GXP systems transition, related to change control and regulatory dossiers
• Ad hoc RACMC support to line manager
• Assist with post-approval and investigational life cycle management as needed, including but not limited to post approval supplements and variations, annual reports, and investigational (IND/IMPD) amendments, per team and program timelines.
• The outlined tasks may be subject to change as the workload of the business requires
Desired Abilities
• Experience in regulatory submissions roles, supporting the compilation of module 3 components of a submission, related Quality/CMC documents and components, and regulatory briefing documents
• Good writing skills for technical writing
• Detail oriented and highly organized
• Good verbal communication skills for leading meetings and remote interactions
• Work well in team setting on a fast-paced business critical project
• Excellent oral and written communication skills for effectively interfacing with higher levels of management and departments within the company

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.


20/05/2022 12:00:00
USD 111.56 111.56 Hour
Contact Consultant:
Sam Royall

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