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Randstad Regulatory Affairs CMC Lead in cambridge, Massachusetts

Regulatory Affairs CMC Lead

job details:

  • location:Cambridge, MA (remote)

  • salary:$55 - $65 per hour

  • date posted:Wednesday, April 7, 2021

  • job type:Contract

  • industry:Manufacturing

  • reference:832403

job description

Regulatory Affairs CMC Lead

job summary:

Need a temporary resource for small molecule development programs. Specifically, regulatory CMC professional with small molecule development experience. Experienced in preparing submissions IND/IMPDs for P 1, 2 and 3 programs and late-stage program support for NDA or MAA) and oversight of development team working on the Asset team.

location: Cambridge, Massachusetts

job type: Contract

salary: $55 - 65 per hour

work hours: 9am to 5pm

education: Bachelors

responsibilities:

REQUIRED SKILLS:

1) Regulatory Affairs, Small molecule CMC experience - specifically global CMC focus on IND, IMPD and CTA submissions and Agency response to questions.

2) Ideally experience with coordinating or contributing to global filing CTD content within M3.

3) Regulatory experience with global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products.

ADDITIONAL REQUIREMENTS:

1) Experienced in technical/regulatory writing.

2) Successful authoring and contribution to delivering CMC submission documents of development.

3) Good communication skills and experience working cross-functionally and globally. Quick learner and able to navigate electronic systems to find information and apply to the given program.

4) Ability to work, with responsibility, both independently and within project teams or committees to attain group goals and key project milestones.

qualifications:

  • Experience level:

  • Education: Bachelors

skills:

  • regulatory affairs

  • CMC

  • small molecule

  • CTD

  • Common Technical Document

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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