70 applicantsPosted by Agency
Beacon Hill Staffing Group · 2 days ago
Senior Manager of Regulatory Affairs
United States
Contract
Remote
Senior Level
$75/hr - $80/hr
12+ years exp
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Hiring Manager
Laura (Gaidar) DelCoiro
Insider Connection @Beacon Hill Staffing Group
Responsibilities
Manage submissions and projects as assigned by Regulatory leadership assuring compliance, planning, and execution
Represent regulatory on cross-functional teams
Process, interpret and provide recommendations for complex strategies
Provide regulatory and technical expertise to cross-functional teams
Critically review documentation for regulatory submissions and provide input for necessary revisions
Develop and implement regulatory strategies for CMC aspects of drug development and registration
Lead the preparation and submission of CMC sections of regulatory documents (e.g., INDs, NDAs, BLAs, MAAs) in compliance with global regulations and guidelines
Contribute to defining Target Product Profile and build compliant drug “approvable” dossiers and registration
Serve as Liaison for third party service providers
Maintain associated database for tracking individual and department project deliverables for regulatory submissions and milestones
Develop and implement policies, procedures, practices, and strategies for Regulatory Affairs, based on current Health Authority guidelines and regulations
Manage multiple, sometimes conflicting priorities, define issues and obstacles, define risk analysis and execute solutions
Execute objectives in alignment with Regulatory leadership, Marketing, and Global Business Units
Communicate regulatory governmental policy changes to management in a timely manner and provide plans for meeting and complying with new requirements. Understand and recommend strategies based on current local registration requirements and applicable industry standards
Support the professional development of regulatory staff through mentorship and guidance
Present to upper management at required intervals and effectively communicate successes and challenges
Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)
Qualification
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Required
Bachelor of Science in Chemistry, pharmacy, biology or other life science, plus direct experience managing regulatory activities.
Twelve or more years of relevant Regulatory Affairs pharmaceutical industry experience.
Two years of supervisory experience of direct reports required, matrix management experience preferred.
In-depth knowledge of global CMC regulatory requirements, guidelines, and industry practices.
Experience in leading new project submission efforts including strategy, compilation, submission, and approval by a health authority.
Experience writing Target Product Profiles, non-clinical studies, reviewing Clinical protocols and summary reports.
Preparing for and executing Health Authority meetings.
Company
Beacon Hill Staffing Group
Beacon Hill Staffing Group is a Staffing and Recruiting company.
1,001-5,000 employees
H1B Sponsorship
Beacon Hill Staffing Group has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (57)
2022 (62)
2021 (73)
2020 (77)
Funding
Current Stage
Late StageLeadership Team
Amber Leslie
Executive Assistant to CEO
Amy Van Sicklin
Chief Culture Officer
Recent News
2023-12-22
Company data provided by crunchbase
