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Sr. Manager / Associate Director, Regulatory Affairs-CMC

Job Description:

This role’s primary responsibility is to partner with Regulatory Therapy Area leadership and serve as CMC representative on assigned teams and related technical projects associated with commercial and development CMC activities. This Sr. Manager position will be responsible for obtaining, preparing, submitting and maintaining regulatory filings for domestic and international regions, coordinating submission activities with internal team members and external parties (e.g., regulatory bodies; vendors; consultants), maintaining up-to-date information on regulatory requirements and product submissions.


Responsibilities:

  • Participate as RegCMC Lead in CMC project-related team meetings; will involve multiple CMC projects (investigational and commercial)
  • Work to align with the RA Therapy Area Lead to research and prepare the CMC strategy for timely submission of investigational products to FDA, and other Regulatory Authorities.
  • Responsible for ensuring commercial CMC submissions are identified and submitted per schedule from RA Therapy Area Lead<./li>
  • Capable of rapid adaptation should strategy & unanticipated changes occur.
  • Lead and coordinate the timely compilation and critical review of the CMC data package from other functional team representatives to provide complete and appropriate documentation necessary for timely FDA and ROW submissions.
  • Work with functional experts to provide timely responses to CMC questions from regulatory agencies.
  • Writes CMC dossier from CMC data package and coordinate a comprehensive project team review by functional team members to ensure accuracy of the dossier. May be required to support dossier QC.
  • May be asked to provide input to regulatory negotiations and interactions with regulatory agencies.
  • Communicate with internal and external customers (as applicable) to obtain required supporting documents and data for compilation of the CMC dossier in a timely manner that supports agreed upon project timelines.
  • Coordinate and lead the task of drafting responses to CMC related questions from FDA or foreign health authorities.
  • Keep up to date on industry and regulatory trends as well as CMC-related regulatory requirements and/or national law.
  • Manages the submissions of CMC-related submission components. Assure that completed dossier submissions are tracked until approved and that all stake-holder (internal and external) are apprised of review periods, informed of CMC-related questions during review, informed of approvals, and copies of required submission dossier and/or approvals are distributed to appropriate individuals.
  • May partner with various teams throughout organization (Clinical Operations, R&D, Quality, etc.) on projects.


Requirements:

  • Bachelors or advanced degree preferred (MS, PhD.) in a scientific discipline.
  • Minimum of 5 years of relevant regulatory experience.


Preferred Skills, Qualifications, or Technical Proficiencies:

  • Strong analytical and problem-solving skills.
  • Solid, strong computer skills
  • Strong written and verbal communication skills, including the ability to interact effectively and to influence.
  • Strong scientific and/or technical knowledge pertaining to pharmaceutical development of small molecule new molecular entities (NMEs).
  • Strong attention to detail.
  • Customer focused and adaptable, with the ability to balance and manage multiple projects from multiple stakeholders to time and quality expectations.
  • High functioning as both a team player and individual contributor.
  • Achievement-oriented with appropriate concern for quality are highly desirable
  • Record of achievement of regulatory submissions (approvals a plus) and demonstrated success in working with regulatory authorities and/or toll manufacturers.
  • In depth knowledge of U.S. and European Regulatory and pharmaceutical issues
  • CMC support of new pharmaceutical and/or marketed pharmaceutical products worldwide
  • Extensive customer interactions with R&D functions, QA, Manufacturing and other teams within Regulatory Affairs
  • Demonstrated understanding of small molecule CMC attributes, including analytical (methodology and specification) experience


If you are interested, please submit your resume by email to hr@corcept.com

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