(Contractor) Senior Manager Regulatory Affairs

The Senior Manager of Regulatory Affairs is responsible for Nuclear Medicine Regulatory Affairsdossiers and associated regulatory affairs activities in the US. The responsibilities include, yet arenot limited to, defining and or authoring compliant content for new and existing dossiers,implementing and managing tracking systems, and preparation of electronic submissions. Thisposition requires a highly skilled and experienced individual capable of navigating the complexregulatory landscape related to CMC. The main focus of this position will be on new submissionsassociated with new chemical entity (NCE) with a secondary focus on existing marketed products orthose 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 andclinical), Non-clinical and clinical protocol review, defining dossier Table of contents, submissionbuilding, health authority management, obtaining approvals, managing post-approval commitments,and product launch. The regional focus for project deliverables is North America, that is, Food andDrug Administration and Health Canada, although the position will rely on the Canadian RA staff forcountry-specific regulations.
The Senior Manager Regulatory Affairs will directly participate in project teams managing keyprojects, regulatory deliverables, prioritization, strategy, providing guidance, and tracking regulatoryprocess. The Senior Manager is expected to be able to identify risk and make risk-based decisions tofacilitate solutions for process and submission. The candidate will direct and mentor lessexperienced staff on Risk-Based Decision making.

Work Schedule: 8am - 5pm

• Manage submissions and projects as assigned by Regulatory leadership assuringcompliance, 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 fornecessary revisions
• Develop and implement regulatory strategies for CMC aspects of drug development andregistration
• 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 deliverablesfor regulatory submissions and milestones
• Develop and implement policies, procedures, practices, and strategies for RegulatoryAffairs, based on current Health Authority guidelines and regulations
• Manage multiple, sometimes conflicting priorities, define issues and obstacles, define riskanalysis and execute solutions
• Execute objectives in alignment with Regulatory leadership, Marketing, and GlobalBusiness Units
• Communicate regulatory governmental policy changes to management in a timely mannerand provide plans for meeting and complying with new requirements. Understand andrecommend strategies based on current local registration requirements and applicableindustry standards
• Supports the professional development of regulatory staff through mentorship andguidance
• Present to upper management at required intervals and effectively communicatesuccesses and challenges
• Must maintain operational compliance with US and international regulatory agencies andguidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)

• Bachelor of Science in Chemistry, pharmacy, biology or other life science, plus directexperience managing regulatory activities.
• Twelve or more years of relevant Regulatory Affairs pharmaceutical industry experience.
• Two years of supervisory experience of direct reports required, matrix managementexperience preferred.
• In-depth knowledge of global CMC regulatory requirements, guidelines, and industrypractices.
• 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 Clinicalprotocols and summary reports.
• Preparing for and executing Health Authority meetings.

Working Conditions:

• Standard office environment.
• Willingness to work in a team-based environment.
• May be required to sit or stand for long periods of time while performing duties.
• Close attention to detail required.
• Must be able to work outside of regular work hours, including off shift, weekend, andholiday work as business needs require.