Associate Director, Regulatory Affairs CMC & Operations

It's fun to work in a company where people truly BELIEVE in what they're doing!

We're committed to bringing passion and customer focus to the business.
 

Corium is a privately held commercial stage biopharmaceutical company leading the development and commercialization of CNS therapies that provide clinicians with new treatment options for patients, caregivers, and their families. With two recent NDA approvals, ADLARITY® (2022) and AZSTARYS® (2021) and a robust pipeline, Corium is focused on addressing unmet needs in the treatment of patients with CNS conditions.

Our company values are core to our positive and people-centric culture which inspires all of us to come to work every day on behalf of our people, our partners, our customers, and our patients. Through our four core values, we work to Turn Life Into Living – to put people first and create opportunities to make each day better than the last.

• Celebrate Individuals: We’re looking for talent who will celebrate the uniqueness of each of our team members by encouraging everyone to bring their authentic self to work.
• Successful Together: We believe we’re better together so we prioritize teamwork as we work to achieve our shared vision knowing each one of us has an important role to play.
• Welcome Opportunities: We prioritize a flexible approach, which welcomes new challenges and opportunities to best meet the needs of our people, our partners, our customers, and our patients.
• Pride in Ownership: We take pride in owning our progress and successes, feeling empowered to pursue our growth to reach our full potential. And we hope you will too!

The Associate Director, Regulatory Affairs (RA) CMC and Operations is responsible for the management of regulatory operations activities including project planning, tracking, and health authority submissions. This role will lead Regulatory Affairs CMC activities under the direction of RA leadership including the development and implementation of regulatory CMC strategy, submissions, and compliance activities for programs to support regulatory approvals and post approval activities enabling Corium to bring novel products to patients to address unmet medical needs. This role will report to the Head of Regulatory Affairs and work closely with different groups including tech ops, legal, clinical development and medical affairs to support all products throughout their lifecycle.

Summary of Responsibilities

Percentage of Time - 40%

• 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.

Percentage of Time - 40%

• 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.

Percentage of Time - 10%

• 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.

Percentage of Time - 10%

• 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.

Required Education and Experience

• 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

Key Skills and Competencies

• 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