Sr Regulatory Affairs Consultant ( AD Level) Apply Now
Location:
Employment Type: Contract
Job Description
Title: Sr Regulatory Affairs Consultant ( AD Level)
Location: Remote (manager is in PDT)
Work Arrangement: Remote
Employment Type: Contract
Duration: 12m+
Location: Remote (manager is in PDT)
Work Arrangement: Remote
Employment Type: Contract
Duration: 12m+
About the Role
The Associate Director, Regulatory Affairs, will oversee and coordinate global regulatory activities supporting the organization development programs. This role ensures the timely planning, preparation, submission, and tracking of regulatory deliverables across regions (e.g., FDA, Health Canada, EMA, MHRA, TGA), working in close partnership with internal teams and external vendors. This role serves as the operational driver for regulatory submissions and key regulatory milestones-facilitating cross-functional alignment, ensuring compliance with regional requirements, and maintaining full visibility of submission readiness, timelines, and...Key Responsibilities
- Regulatory Planning & Execution
- Develop and manage detailed regulatory project plans, including timelines, deliverables, and dependencies for IND, CTA, and NDA-related submissions.
- Coordinate preparation, QC, and dispatch of regulatory submissions and responses to health authority queries.
- Track deliverable progress, identify risks or delays, and proactively drive issue resolution to meet filing timelines.
- Cross-Functional Leadership
- Serve as the central point of contact among Regulatory, CMC, Clinical, Nonclinical, QA, Medical Writing, and CRO partners.
- Facilitate team meetings, define next steps, assign responsibilities, and ensure completion of follow-up actions.
Required Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related discipline (advanced degree preferred).
- 8-10 years of experience in regulatory affairs or regulatory project management within a pharmaceutical or biotech environment.
- Proven record in coordinating major submissions (INDs, CTAs, NDAs) and supporting global regulatory interactions.
- Small molecule experience is required.
- Strong knowledge of Health Canada, FDA, and EMA processes and expectations.
- Skilled in Smartsheet, MS Project, Excel trackers, and regulatory document control systems (eCTD, RIM).
- Excellent communication, organization, and stakeholder management skills with a strong attention to detail.
Key Skills
Excel | Quality Assurance | Regulatory Affairs | CMC | Project ManagementCompensation
In accordance with applicable pay transparency requirements, the anticipated compensation for this role is $90.00 - $97.00/hr, based on experience and qualifications.Contact
Christian Griffith
Principal Recruiter
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