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Company

Corium · 14 hours ago

Associate Director, Regulatory Affairs CMC & Operations

Massachusetts, United States

Full-time

Remote

Director/Executive

10+ years exp

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BiopharmaHealth Care

H1B Sponsor Likely

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Responsibilities

Manage the development of high-quality regulatory documents, including direct authoring and/or reviewing of documents such as submissions, meeting requests and briefing documents, and responses to regulatory requests for information while adhering to timelines, company standards, and industry best practices.

Responsible for regulatory submissions for products including small molecule and transdermal derived products. Includes preparation writing, submission and coordination with external resources for IND, NDAs and other submissions. Ensure that regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements.

Critically review and provide meaningful and strategic input on regulatory filing documents (e.g. pre-INDs, INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements) to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics.

Perform final review and approval of the compliance activities of the portfolio to confirm regulatory impact and associated submission requirements for clinical and commercial regulatory filings in accordance with country specific regulatory guidance documents.

Oversee external eCTD vendor and ensure compliance with internal practices.

Lead CMC Reg Affairs (RA) product development activities during early phase, development, market applications, and post market requirements with input from senior management.

Represent CMC RA at program meetings and provide regulatory assessment and input into strategy development for CMC activities.

Proactively identify program issues and work with leadership to develop appropriate regulatory strategies to mitigate risks to filings, independently find alternative solutions/work-arounds, and obtain buy-in from organization leadership.

Contribute to the development and implementation of internal processes, including work instructions and SOPs related to a broad range of regulatory activities.

Identify opportunities for improvement of processes for compliance tasks.

Maintain up-to-date knowledge of FDA laws, regulations and guidances, as well as the compliance environment. Keep up to date on regulatory precedence from competitor products, prior approvals, and relevant external programs.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Regulatory AffairsCMC experienceFDA regulationsIND submissionsNDA submissionsECTD formatCross-functional collaboration

Required

BA/BS in related field, advance degree (MSc, MPH, PharmD, PhD, MD) preferred

Minimum of 10 years pharma/biotech industry experience including a minimum of 5 years of relevant CMC experience

Experience with IND, NDA, other regulatory submissions, and product life cycle activities

Thorough understanding of FDA regulatory requirements

Experience managing FDA regulatory submissions activities and external submissions vendors

Experience with publishing software for regulatory submissions in Electronic Common Technical Document (eCTD) format

Demonstrated ability to work effectively in a cross-functional environment

Detail-oriented and highly organized

Works independently and under tight deadlines

Able to resolve conflicts in a positive and collaborative manner

Company

Corium

Corium is a commercial-stage biopharmaceutical company that treats conditions of the central nervous system.

Founded in 1999

Grand Rapids, Michigan, USA

201-500 employees

https://corium.com

H1B Sponsorship

Corium has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2023 (1)