The Senior Manager of Regulatory Affairs is responsible for Regulatory Affairs dossiers and associated regulatory affairs activities in the US. The responsibilities include, yet are not limited to, defining and or authoring compliant content for new and existing dossiers, implementing and managing tracking systems, and preparation of electronic submissions. This position requires a highly skilled and experienced individual capable of navigating the complex regulatory landscape related to CMC. The main focus of this position will be on new submissions associated with new chemical entity (NCE) with a secondary focus on existing marketed products or those obtained through acquisition.
This position will facilitate the success of key regulatory projects that may require concept building, Target Product Profile (TPP), claims definition, regulatory strategy (including non-clinical and clinical), Non-clinical and clinical protocol review, defining dossier Table of contents, submission building, health authority management, obtaining approvals, managing post-approval commitments, and product launch. The regional focus for project deliverables is North America, that is, Food and Drug Administration and Health Canada, although the position will rely on the Canadian RA staff for country-specific regulations.
The Senior Manager Regulatory Affairs will directly participate in project teams managing key projects, regulatory deliverables, prioritization, strategy, providing guidance, and tracking regulatory process. The Senior Manager is expected to be able to identify risk and make risk-based decisions to facilitate solutions for process and submission. The candidate will direct and mentor less experienced staff on Risk-Based Decision making.
Essential Functions
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
Supports 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.)
Requirements
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.
Preparing for and executing Health Authority meetings.
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
Company Profile:
Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.
Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.
Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.beaconhillstaffing.com .
