CMC Regulatory Manufacturing Support Positions - All levels
Date Posted [Sep-29-09] (ID: 93935)
OVERVIEW:
Individual will be a member of an interdisciplinary team that will provide support to the Regulatory Affairs (CMC) Organization. This team’s primary responsibility will be to provide the technical content for the Chemistry, Manufacturing and Controls (CMC) sections of all investigational drug applications (INDs, CTAs) and any required amendments, initial marketing applications along with any required supplements and amendments. Additional responsibilities include assisting the RA (CMC) Group with the compilation of the responses to the respective health authorities resulting from the noted filings, coordinating and synthesizing input from the required technical experts. Must be detail-oriented with good oral and written communication skills. Must be able to multi-task and to keep to the timelines established for the respective filings.
Responsibilities include:
1. Responsible for generating the technical content for the Chemistry, Manufacturing and Controls (CMC) documentation required for investigation new drug applications and their respective amendments as well as initial marketing applications along with the required supplements and amendments.
2. Using standardized templates prepare the respective technical sections for a given regulatory filing.
3. Coordinate the completion of the CMC templates with the Regulatory Affairs (CMC) Organization for those filings assigned.
4. Summarize technical reports and documents to meet the needs of a given template section.
5. Maintain a working knowledge of the project plans for those projects where you are a contributor to ensure that the CMC sections are delivered on time. As required, lead the efforts for a given filing. This will required a project plan to be maintained based on the deliverables established by the product project teams and the filing schedule established by the Regulatory (CMC) Affairs organization.
6. As required serve as a member of multi-disciplinary teams organized to ensure project timelines are met and clinical and commercial supplies are available when needed.
7. Assist manager with the mentoring of the teams less experienced members.
8. Assist manager with the preparation of an optimized work flow for document creation, review and completion.
Requirements
Minimum of 7-15 years Biopharmaceutical or Pharmaceutical Industry (Credit given toward years of industry experience to those with advanced degrees.)
1-5+ years in a Regulatory role including handling/authoring of CMC for IND, CTA, Marketing Applications, and BLA
A working knowledge of US regulatory requirements with global regulatory experience a plus.
A working technical knowledge of the biopharmaceutical manufacturing process preferably in the area of antibody manufacturing. Expertise in a technical discipline a plus.
Working knowledge of cGMPs as they apply to the Regulatory environment.
Strong organizational and project management skills.
Excellent communication skills, both oral and written with demonstrated skills in the preparation of complex regulatory filings.
EDUCATION:
BS/BA degree in Biochemistry, Chemistry, Microbiology, Pharmaceuticals, Chemical Engineering or related field. An advanced degree a plus
Above requirements are for Director level - there are varying level positions available in this department - please do contact debbie.wilmer@discoverysolutions.net for more information
Individual will be a member of an interdisciplinary team that will provide support to the Regulatory Affairs (CMC) Organization. This team’s primary responsibility will be to provide the technical content for the Chemistry, Manufacturing and Controls (CMC) sections of all investigational drug applications (INDs, CTAs) and any required amendments, initial marketing applications along with any required supplements and amendments. Additional responsibilities include assisting the RA (CMC) Group with the compilation of the responses to the respective health authorities resulting from the noted filings, coordinating and synthesizing input from the required technical experts. Must be detail-oriented with good oral and written communication skills. Must be able to multi-task and to keep to the timelines established for the respective filings.
Responsibilities include:
1. Responsible for generating the technical content for the Chemistry, Manufacturing and Controls (CMC) documentation required for investigation new drug applications and their respective amendments as well as initial marketing applications along with the required supplements and amendments.
2. Using standardized templates prepare the respective technical sections for a given regulatory filing.
3. Coordinate the completion of the CMC templates with the Regulatory Affairs (CMC) Organization for those filings assigned.
4. Summarize technical reports and documents to meet the needs of a given template section.
5. Maintain a working knowledge of the project plans for those projects where you are a contributor to ensure that the CMC sections are delivered on time. As required, lead the efforts for a given filing. This will required a project plan to be maintained based on the deliverables established by the product project teams and the filing schedule established by the Regulatory (CMC) Affairs organization.
6. As required serve as a member of multi-disciplinary teams organized to ensure project timelines are met and clinical and commercial supplies are available when needed.
7. Assist manager with the mentoring of the teams less experienced members.
8. Assist manager with the preparation of an optimized work flow for document creation, review and completion.
Requirements
Minimum of 7-15 years Biopharmaceutical or Pharmaceutical Industry (Credit given toward years of industry experience to those with advanced degrees.)
1-5+ years in a Regulatory role including handling/authoring of CMC for IND, CTA, Marketing Applications, and BLA
A working knowledge of US regulatory requirements with global regulatory experience a plus.
A working technical knowledge of the biopharmaceutical manufacturing process preferably in the area of antibody manufacturing. Expertise in a technical discipline a plus.
Working knowledge of cGMPs as they apply to the Regulatory environment.
Strong organizational and project management skills.
Excellent communication skills, both oral and written with demonstrated skills in the preparation of complex regulatory filings.
EDUCATION:
BS/BA degree in Biochemistry, Chemistry, Microbiology, Pharmaceuticals, Chemical Engineering or related field. An advanced degree a plus
Above requirements are for Director level - there are varying level positions available in this department - please do contact debbie.wilmer@discoverysolutions.net for more information
