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CMC Regulatory Affairs Manager

In Massachusetts / United States

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CMC Regulatory Affairs Manager   

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JOB TITLE:
CMC Regulatory Affairs Manager
JOB TYPE:

JOB SKILLS:
JOB LOCATION:
Canton Massachusetts / United States

JOB DESCRIPTION :

Overview:

  • Reporting to the Sr. Director, CMC this position will provide support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs for development products. The incumbent will work closely with subject matter experts and be responsible for assuring the regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality. This is a hands-on role requiring knowledge and experience in the writing and the preparation of CMC sections of regulatory submissions.

Roles and Responsibilities:

  • Prepare and review submission-ready CMC sections for INDs, CTAs, IND annual reports, NDA and MAA applications
  • As a member of the project teams, provide CMC regulatory guidance for global development and registration programs (e.g., INDs, CTAs, NDAs, and MAAs)
  • Assess and communicate CMC regulatory requirements to ensure all development activities are conducted in compliance with applicable regulations and guidelines.
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
  • Provide regulatory support and guidance to various departments, programs, and teams with a strong emphasis on frequent interactions with technical teams.
  • Review technical documentation to ensure regulatory compliance and conformance with existing regulatory applications and approvals.
  • Research and analyze regulatory information and maintain current regulatory knowledge.

Education and Experience:

  • B.S in biochemistry, chemistry, Biology, or related pharmaceutical field
  • Minimum of 1-3 years CMC regulatory affairs experience (or equivalent)
  • Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development
  • Ability to manage complex projects and timelines in a collaborative matrix team environment.
  • Excellent analytical skills
  • Ability to communicate effectively (verbal and written) to multiple levels in the organization with strong negotiation skills.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  • Demonstrated ability to excel in smaller entrepreneurial organizations.

Position Details

S16174661655443705
Massachusetts / United States
Canton
A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

CMC Regulatory Affairs Manager    Apply

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Overview:

  • Reporting to the Sr. Director, CMC this position will provide support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs for development products. The incumbent will work closely with subject matter experts and be responsible for assuring the regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality. This is a hands-on role requiring knowledge and experience in the writing and the preparation of CMC sections of regulatory submissions.

Roles and Responsibilities:

  • Prepare and review submission-ready CMC sections for INDs, CTAs, IND annual reports, NDA and MAA applications
  • As a member of the project teams, provide CMC regulatory guidance for global development and registration programs (e.g., INDs, CTAs, NDAs, and MAAs)
  • Assess and communicate CMC regulatory requirements to ensure all development activities are conducted in compliance with applicable regulations and guidelines.
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
  • Provide regulatory support and guidance to various departments, programs, and teams with a strong emphasis on frequent interactions with technical teams.
  • Review technical documentation to ensure regulatory compliance and conformance with existing regulatory applications and approvals.
  • Research and analyze regulatory information and maintain current regulatory knowledge.

Education and Experience:

  • B.S in biochemistry, chemistry, Biology, or related pharmaceutical field
  • Minimum of 1-3 years CMC regulatory affairs experience (or equivalent)
  • Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development
  • Ability to manage complex projects and timelines in a collaborative matrix team environment.
  • Excellent analytical skills
  • Ability to communicate effectively (verbal and written) to multiple levels in the organization with strong negotiation skills.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  • Demonstrated ability to excel in smaller entrepreneurial organizations.