Senior Manager, Regulatory CMC

Posted on Nov 18, 2018 by Affinity Executive Search

Buffalo, NY 14201
Senior Appointments
Immediate Start
Annual Salary
Full-Time
POSITION OBJECTIVE:Responsible for leading the CMC (Chemistry, Manufacturing and Controls) regulatory function, the Senior Manager, Regulatory CMC will collaborate cross-functionally to develop the CMC regulatory strategy, provide guidance to broader CMC functions, and drive CMC regulatory filing(s). Working collaboratively with senior leadership to develop CMC regulatory strategies for one or more investigational and/or commercial products this position will lead the preparation and filing of regulatory CMC submissions and manage the interactions with all Health Authorities for CMC topics. This individual will provide CMC regulatory support and guidance to various cross-functional teams and ensure all applicable regulatory requirements are considered and appropriately incorporated into clinical and commercial products.

MAY CONSIDER CANDIDATES BEING LOCATED IN CRANFORD, NJ, SCHAUMBURG, IL, OR POSSIBLY REMOTE BUT PREFERENCE IS FOR BUFFALO UNLESS WE CANT FIND ANYONE!!!

ESSENTIAL JOB FUNCTIONS/RESPONSIBILITIES

* Plans, manages, and executes CMC regulatory activities for assets in various phases of development.
* Responsible for the coordination, authorship, preparation, review and timely filing and maintenance of regulatory submissions (INDs, NDAs, CTAs, amendments, safety reports, annual updates, briefing documents, pre-meeting packages, post approval submission and marketing applications to FDA and international regulatory authorities), which support clinical programs, CMC and quality.
* Provides quality/CMC review for clinical study protocols, clinical study reports, investigator brochures and other relevant reports.
* Develops and implements CMC Regulatory strategies for assigned projects and provides advice and strategic guidance to development teams.
* Serves as the CMC regulatory lead on relevant project teams and subteams.
* Develops and communicates regulatory CMC strategy, identifying key issues and remediation activities needed throughout project/product life cycle.
* Serves as the Regulatory lead in Health Authority meetings and leads preparation of CMC activities for meetings with Health Authorities.
* Interacts directly and indirectly with FDA and international Health Authorities, as necessary.
* Ensures line management and key stakeholders are apprised of ongoing developments.
* Maintains current knowledge of relevant US and international guidances, laws and regulations, and proposed and final rules which affect CMC pharmaceutical drug development.

REQUIRED EDUCATION & QUALIFICATIONS

* BA/BS degree is required. Advanced degree (M.S. or Pharm.D.) in scientific, Regulatory Affairs, or related pharmaceutical field preferred.
* 8 to 10 years pharmaceutical industry experience with a minimum of 5 years in regulatory affairs CMC or a related pharmaceutical development field. Experience with global clinical trial and marketing applications, eCTD submissions and electronic document management systems, highly desirable.
* Established working knowledge of pharmaceutical drug development and related global CMC regulations/guidelines.
* Evidence of successful submissions to FDA (e.g., NDAs, INDs, briefing packages) and demonstrated evidence of writing of regulatory documents.
* Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions and/or product development meetings.
* Strong knowledge of eCTD elements and structure and regulatory writing skills.
* Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
* Strong communication skills both written and oral.
* Ability to multi-task and shift priorities rapidly to meet tight deadlines.
* Detail oriented and well organized.
* Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
* Proficient in Microsoft Office suite and applications.

Reference: 559198871

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