Senior Director - CMC, Regulator Affairs

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Location

Waltham, MA

Summary

The Senior Director – CMC, Regulatory Affairs provides strategic and tactical direction to assigned projects ensuring that all U.S. and international regulatory requirements concerning chemistry, manufacturing, and controls (CMC) of human pharmaceutical products are met during the development of new products and during the life cycle of U.S. marketed products.  

Full Description

The Senior Director – CMC, Regulatory Affairs provides strategic and tactical direction to assigned projects ensuring that all U.S. and international regulatory requirements concerning chemistry, manufacturing, and controls (CMC) of human pharmaceutical products are met during the development of new products and during the life cycle of U.S. marketed products.  This individual leads the planning and compilation and submission of CMC documentation to regulatory agencies and is the primary contact with Chemistry staff at FDA and other agencies for assigned projects. This individual leads the CMC Regulatory function at Acorda.


*Essential Duties and Responsibilities
include the following.  Other duties may be assigned.

  • Provides CMC regulatory guidance on investigational drug projects and marketed products, including construction of CMC dossiers, submission strategies and handling of post-approval changes.
  • Ensures that the CMC information in Acorda’s regulatory submissions is in compliance with applicable laws and federal regulations.
  • Responsible for direct communications between Acorda and regulatory authorities on all CMC-related issues; interacts with senior-most CMC staff at regulatory authorities as needed.
  • Assists with the scientific review and writing of IND and NDA/MAA CMC documentation.
  • In cooperation with project management, develops and monitors timelines on assigned projects, including progress updates to senior management on development projects.
  • Provides ongoing performance review, feedback and development of staff.
  • Assists with talent recruitment and leads a highly motivated, efficient and effective team.
  • Responsible for training and mentoring associates on the Regulatory Affairs Team.

 Education and/or Experience:

  • Bachelor’s degree in a relevant technical, scientific discipline (e.g., Chemistry, Biology or Pharmaceutical Science) required; advanced
  • Advanced degree in a relevant technical, scientific discipline (e.g., Master’s PharmD or PhD) preferred.
  • Minimum of seven years of management experience preferred.
  • Minimum of ten years of progressive experience in a CMC regulatory function. Applicable experience in a relevant technical function may be considered (e.g., a leadership role in CMC development work conducted per ICH guidelines, in authoring Module 3 CMC documents, in addressing FDA requests for CMC information, etc.)
  • Minimum of 15 years’ experience in scientific or technical roles pharmaceutical or biotechnology industries.
  • Prior regulatory functional responsibility preferred

 Supervisory Responsibilities:

 This position supervises associates on the CMC team.

 Qualifications:

  • Extensive knowledge of US and international CMC regulatory requirements required.
  • Must have demonstrated successful experience in filing INDs/NDAs.
  • Ability to apply knowledge both strategically and operationally to assigned development projects and marketed product regulatory issues to resolve technical regulatory issues.
  • Prior experience in the development of both small molecules and biological products is preferred.

 Computer Skills:

 Must be proficient in MS Office Suite.

  • Prior experience with DocCompliance and MedXview or other web-based document management/publishing software for electronic submissions is preferred.

 Certificate, Licenses, Registrations:

 Regulatory Affairs Certification (US), (EU) or (CAN) preferred.

 Other Skills and Abilities:

  • Excellent writing, communication, and presentation skills.
  • Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast paced environment.
  • Strong skills in planning, organizing, decision-making and problem-solving.
  • Demonstrated leadership and project management skills.
  • Ability to serve on multiple interdepartmental teams and to act as team leader when appropriate.
  • Demonstrated ability to stay abreast of trends and new information.

 Physical Demands:

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  •  This position requires travel; the average travel for this position is 10-15% (both domestic and international including overnight) with some variation based upon the demands of the business imperatives.

 Work Environment:

 The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

  •  No specific work demands.

 *To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions