Associate Director/Director, Regulatory CMC
The position requires knowledge and experience of biologics and/or pharmaceuticals and preferably gene therapy medicinal products. The incumbent must possess technical expertise in the area of responsibility and demonstrate effective problem-solving, strong understanding of global regulatory affairs submissions and management skills and the ability to prioritize multiple tasks.
Responsibilities include:
* Act as the primary regulatory CMC contact at the site comprising end to end manufacturing of biologicals (drug substance, drug product, QC testing and packaging operations).
* Working on site for at least 2 days a week is expected.
* Working closely with Quality assurance, Quality Control and Manufacturing groups to assure the relevant product and regulatory expectations are met;
* Manage a small team of regulatory CMC professionals at the site. Brand the excellent work of the regulatory team at site meetings and at global regulatory meetings.
* Primary regulatory CMC contact with contract manufacturing organizations (CMOs) based in Europe, as required.
* Lead global marketing authorisations, renewals and post-approval changes for biological products, drug-device combination products and/or small molecules.
* This role includes compilation of all necessary documentation for global regulatory submissions.
* Ensure submissions and responses to regulatory questions are of high quality and right first time; that content and format of regulatory submissions comply with application regulations and guidance governing the development, licensure and marketing of drugs, biologics and /or gene therapy medicinal products.
* Lead regulatory CMC support for impact assessment to change control, deviation and cGMP inspection readiness at the site.
* Coordinate and track regulatory commitments related to drug substance and drug product technology transfers.
* Lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and personalities.
* Demonstrate initiative and have the ability to work independently and collaboratively in a team structure and in a global organization.
Experience:
* Minimum requirement is for a bachelor’s degree in a pharmacy, biological discipline, chemistry, or molecular biology or other science.
* Minimum of 8 years of Regulatory Affairs, CMC experience.
* Proven experience in a leadership role with strong management skills and business acumen.
* Experience with people management preferred.
* Understanding of drug development, technology transfers and working under accelerated timelines.
* Outstanding interpersonal and communication (written and verbal) skills is required.
* Strong writing and editing skills for technical documentation.
* Proficient with computer and standard software programs.
* Able to travel 10%.
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