Remote: Regulatory Submissions Project Manager- (232477)

Life Sciences & Technology
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Job Description 

Job Description: Our client is looking for a Regulatory Project Manager for their Global Submissions Team. They are looking for a candidate that has experience in INDs/NDAs/BLAs/MAAs/CTAs, but this candidate will not be authoring the documents, rather they will be leading the project and strategy for their submission. Experience with Health Authority interactions and preparations is a huge plus (EMA/FDA/ROW) however this person will NOT be the direct POC for the health authority interactions.

Submission delivery strategy of all dossiers and all application types.
Review of documents (e.g. response documents, study protocols, PSRs, etc.).
Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
Use and share best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work,
Lead and/or contribute to the planning, preparation, and delivery of submissions throughout the product’s lifecycle from either a global and/or regional perspective.
Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.

Required Skills

Experience over Education

 

Remote: Regulatory Submissions Project Manager- (232477)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
Remote

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