Regulatory Manager

Regulatory Manager
  • $111.56 per Hour
    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.

DAY SHIFT AVAILABLE

Location: Remote

Description:

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.

#LI-SR1

SRGTalent https://www.srgtalent.com https://www.srgtalent.com/-/media/srg/1---new-website/logos/website-logo-all-padding-removed.png
20/05/2022 12:00:00
USD 111.56 111.56 Hour
Contact Consultant:
Sam Royall

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