Sr. Manager Regulatory

3 weeks ago

Boston, United States Scientific Search Full time

Sr. Manager Regulatory Affairs - CMC

Location: Remote

Industry: Biopharma

Contract: 1 year contract

Our California based biopharmaceutical client working in the rare disease space with one approved product and others behind it has tasked our team in finding them a Regulatory Affairs Consultant for a 1 year contract assignment. Working with the product leads, the Sr. Manager CMC Regulatory Affairs provides strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls). This role will assist with the global marketing applications and global post approval CMC activities. The position will be responsible for CMC-related submission planning and for ensuring that high quality and accurate submission documents are provided within agreed upon timelines.

Responsibilities

Support RA CMC with the filing of original and post-approval international registrations. Ensure CMC dossiers meet ICH requirements, as well as country specific requirements. Manage and maintain regulatory CMC submission tracker and documents for global dossier management at initial application and post-approval stages. Performs CMC Regulatory Operations activities to assure a smooth submission process. Support authoring of meeting requests, briefing documents, responses to health authority inquiries, IND/IMPD amendments, post approval changes, and relevant annual updates. Development and implementation of CMC regulatory strategy for global market applications. Provides regulatory support on technical and quality activities, such as manufacturing process development, specifications, in process controls, stability protocols, change control management, and product and compliance quality initiatives. Support the preparation of risk assessments on CMC regulatory topics and quality change control management.

Requirements:

Minimum 2 years of relevant experience in CMC Regulatory Affairs. Experience in drug development, market applications and commercial lifecycle including quality change management. Experience with small molecule regulatory CMC preferred. Understanding of multiple drug product dosage forms preferred. Experience in preparing IND, CTAs, IMPDs, NDAs, and Rest of World filings Knowledgeable of GCP, GXP requirements, ICH, and FDA/EMA guidelines. Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts, and draw valid conclusions.

For immediate consideration please email Tom O’Hanlon at Tom@Scientificsearch.com #J-18808-Ljbffr

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