Beacon Hill Staffing Group, LLC
Director of Regulatory Affairs- Strategy - LSNJN-CR_******** _11-4658
Boise ,
Idaho
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This job was posted by https://idahoworks.gov : For more information,please see: https://idahoworks.gov/jobs/2258971
Summary of Position
The Director of Regulatory Affairs is responsible for Nuclear MedicineRegulatory Affairs dossiers and associated regulatory affairs activitiesin the US. The responsibilities include, yet are not limited to,defining and or authoring compliant content for new and existingdossiers, implementing and managing tracking systems, and preparation ofelectronic submissions. The main focus of this position will be on newsubmissions associated with new chemical entity (NCE) as well asproducts already in non-clinical and/or clinical studies. This positionwill have a secondary focus on existing marketed products or thoseobtained through acquisition.
This position will facilitate the success of key regulatory projectsthat may require concept building, Target Product Profile (TPP), claimsdefinition, regulatory strategy (including non-clinical and clinical),Non-clinical and clinical protocol review, defining dossier Table ofcontents, submission building, health authority management, obtainingapprovals, managing post-approval commitments, and product launch. Theregional focus for project deliverables is North America, that is, Foodand Drug Administration and Health Canada, although the position willrely on the Canadian RA staff for country-specific regulations.
The Director of Regulatory Affairs will directly participate in projectteams managing key projects, regulatory deliverables, prioritization,strategy, providing guidance, and tracking regulatory process. TheSenior Manager is expected to be able to identify risk and makerisk-based decisions to facilitate solutions for process and submission.The candidate will direct and mentor less experienced staff onRisk-Based Decision making.
Essential Functions
Manage submissions and projects as assigned by Regulatory leadershipassuring compliance, planning, and execution
Represent regulatory on cross-functional teams
Process, interpret and provide recommendations for complexstrategies
Provide regulatory and technical expertise to cross-functional teams
Critically review documentation for regulatory submissions andprovide input for necessary revisions
Contribute to defining Target Product Profile and build compliantdrug \"approvable\" dossiers and registration
Serve as Liaison for third party service providers
Maintain associated database for tracking individual and departmentproject deliverables for regulatory submissions and milestones
Develop and implement policies, procedures, practices, andstrategies for Regulatory Affairs, based on current Health Authorityguidelines and regulations
Manage multiple, sometimes conflicting priorities, define issues andobstacles, 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 ina timely manner and provide plans for meeting and complying with newrequirements. Understand and recommend strategies based on currentlocal registration requirements and applicable industry standards
Supports the professional development of regulatory staff throughmentorship and guidance
Present to upper management at required intervals and effectivelycommunicate successes and challenges
Must maintain operational compliance with US and internationalregulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S,ISO, USP, NRC, cGMP, etc.)
Requirements
Regulatory Strategy experience
Bachelor of Science in Chemistry, pharmacy, biology or other lifescience, plus direct experience managing regulatory activities
Twelve or more years of relev nt Regulatory Affairs pharmaceuticalindustry experience.
Two years of supervisory experience of direct reports required,matrix management experience preferred.
Experience in leading new project submission efforts includingstrategy, compilation, submission, and approval by a healthauthority.
Experience writing Target Product Profiles, non-clinical studies,reviewing Clinical protocols and summary reports.
Preparing for and executing Health Authority meetings.
Beacon Hill is an Equal Opportunity Employer that values the strengthdiversity brings to the workplace. Individuals with Disabilities andProtected Veterans are encouraged to apply.
Company Profile:
Founded by industry leaders to set a new standard in search, careerplacement and flexible staffing, we deliver coordinated staffingsolutions with unparalleled service, a commitment to project completionand success and a passion for innovation, creativity and continuousimprovement.
Our niche brands offer a complete suite of staffing services to emerginggrowth companies and the Fortune 500 across market sectors, careerspecialties/disciplines and industries. Over time, office locations,specialty practice areas and service offerings will be added
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