The Director is responsible for the Regulatory Chemistry, Manufacturing, and Controls (RCMC) development activities (NDA/BLA/MAA/IND/IMPD) for assigned development projects, as well as Life-Cycle Management development projects for marketed products in accordance with the RCMC Mission: Interactions and Strategic Negotiations with Agencies; Review, Approval, and Release of CMC Submissions for Fileability and Approvability; Strategy and Risk Assessments. This role involves working independently on assigned highly complex activities, with few to no unplanned deficiencies/errors.
Models excellent leadership skills by proactively developing, training and positively influencing the behaviors of all RCMC associates. This is achieved by influencing the performance of others with respect to review/approval/release, strategic negotiations and strategy/risk assessments. Demonstrates knowledge, skill, and ability to model the Sanofi values with respect to people performance/development activities, processes/procedures and external policy/regulation activities.
As GPL (Global Product Lead) or RPS (Regulatory Product Specialist), responsible for the review, approval, and release of the CMC section of a high-volume of development regulatory submissions (NDAs, BLAs, MAAs and Supplements, INDs/IMPDs and Amendments/Annual Reports) and Life-Cycle-Management projects for marketed products. Submissions are recognized as high quality as demonstrated by limited review rounds and minimal FDA/Health Authority questions. Resolves complex CMC issues by demonstrating in-depth understanding of the regulations and drug development and industrial affairs processes. Develops, recommends, and communicates strategic direction and best possible regulatory position to achieve desired outcomes. Reviews the regulatory submissions of other associates for thoroughness, accuracy, and timeliness. Effective review, approval, and release procedures assure that CMC submissions are of the highest quality while meeting current Health Authority regulatory expectations and business needs according to defined timelines.
As GPL or RPS, responsible for interactions/strategic negotiations with FDA to assure that appropriate and pragmatic RCMC positions can be negotiated with FDA with the highest Probability of Success (POS). Represents sanofi-aventis at FDA meetings and initiates and responds to FDA contacts; builds positive and favorable relations with FDA. Provides input to the interactions/strategic negotiations of other associates. Effective interactions and strategic negotiations with FDA assure that long-term collaborative relationships are developed with FDA CMC Reviewers in order to meet regulatory expectations and business needs according to defined timelines.
Responsible for all RCMC strategic activities related to Change Control and project management (eg, change control teams, dossier preparation teams, submission planning, timelines, tracking and OPX2). Supports the strategic and tactical activities of other associates. Effective involvement and collaboration with other CMC and planning groups assures that RCMC strategies and thought processes are built into regulatory compliance activities practiced in the development departments.
As GPL or RPS, responsible for development of RCMC strategy and risk assessments (SRA) for major CMC activities (eg, INDs, IMPDs, Amendments and MAAs/ NDAs/BLAs). Effectively influences CMC teams to achieve implementation of appropriate regulatory strategies. Builds positive and favorable relations with CMC teams to implement favorable outcomes in the shortest possible time. Provides input to the strategy and risk assessments of other associates. Assures that, for major CMC activities that have a critical regulatory and/or financial impact, appropriate strategies are developed to manage the activities, and risks are identified, communicated, and mitigated as necessary.
Lead the review of internal policies and procedures and external US and international regulatory guidance, trends, policies, and procedures. Anticipates and communicates possible paradigm shifts. Participates on industry and professional teams. Provides strategic support on department initiatives and policies to RCMC Senior Management. Effective internal and external participation on policies, regulations, and guidance is critical to maintaining the expertise and positive image of RCMC in an evolving regulatory environment.
Develop excellent working relationships with internal regulatory and external functional partners; including, vendors and alliances, providing input to business agreements and due-diligence activities. Effective leadership in the RCMC Organization and development of positive working relationships with internal and outside business partners is critical to the success and image of the company.
Qualifications
Advanced degree (MS/MA, PhD) in a science/health field (e.g., Chemistry, Pharmacy, Biology) is highly desirable. Fifteen years of varied and in-depth experience in most aspects of CMC including 10 years in Regulatory CMC and a record of increasing responsibility in Regulatory CMC.
REQUIRED: Small molecule experience.
A strong knowledge of pharmaceutical product development and relevant regulations and guidelines is essential to support registration of development products and life-cycle management projects. Must have an awareness of key Health Authority thinking, anticipatory foresight and be able to assume leadership of projects. Should demonstrate a high level of initiative, independence in thinking and strategic development, and be able to communicate effectively to broad sophisticated audiences both internally and externally.
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