Fraser Dove International · 2 days ago
Senior Manager Regulatory Affairs
United States
Full-time
Remote
Senior Level
5+ years expFraser Dove International is partnering with an innovative biologics organization committed to improving patient lives through high-quality injectable therapies. The Senior Manager of Regulatory Affairs will drive global regulatory strategy and submissions for their biologics portfolio, ensuring compliance with regulatory requirements and building relationships with health authorities.
Human ResourcesRecruitingStaffing Agency
Hiring Manager
Peter Vedde
Responsibilities
Deliver successful BLA submissions and approvals in the US and EU in line with agreed timelines and quality standards
Ensure sustained compliance with global regulatory and good manufacturing practice (GMP) requirements across development, manufacturing and post marketing activities
Build and maintain strong, trusted relationships with key health authorities and internal stakeholders to support the company’s growth and product pipeline
Lead the planning, preparation and delivery of global regulatory submissions to secure initial and lifecycle approvals
Act as a key contact with health authorities including the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), National Medical Products Administration (NMPA), Health Canada and others
Provide clear regulatory advice and cross functional support to quality, production, clinical and other teams to ensure alignment and compliance
Author, review and approve high quality CMC and clinical documents for BLAs and other regulatory applications
Lead and support regulatory inspections and audits, ensuring inspection readiness and effective follow up on any findings
Oversee regulatory aspects of product complaints and compliance issues in close collaboration with the Quality team
Monitor regulatory and industry trends in biologics and advise leadership on potential impact and risk mitigation
Qualification
Required
Significant leadership experience in RA roles within the biologics sector, ideally at senior manager level or equivalent
Proven track record leading successful BLA submissions in the US and EU within the last five years
Deep understanding of GMP and global regulatory compliance principles, with experience supporting regulatory inspections
Strong interpersonal and cross cultural skills, with experience working in a global, multicultural organisation
Ability to collaborate effectively with onsite, hybrid and remote teams, and to represent the organisation confidently to regulators and partners
Bachelor's degree in a life science or related discipline; an advanced degree is preferred
Ability and willingness to relocate to South Korea and to travel internationally as required
Preferred
An advanced degree is preferred
Benefits
Generous compensation
Tax relief
Bonus
House
Car
Company
Fraser Dove International
Fraser Dove International is a talent consultancy that offers recruitment services for life sciences industry.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Joseph Brown
Co-Founder
Company data provided by crunchbase