Director/Associate Director, Regulatory CMC
Hiring Manager: Teresa Pepper ([email protected])
Description
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
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.
Associate Director/Director, Regulatory CMC - Shanbally, Cork
Closing Date - 10th January 2025
Responsibilities include:
- Act as the primary regulatory CMC contact at the BIL 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 the BioMarin International Ltd (BIL) 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 BIL site. Brand the excellent work of the BIL regulatory team at BIL 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 BIL 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.
Education:
- Minimum requirement is for a bachelor’s degree in a pharmacy, biological discipline, chemistry, or molecular biology or other science.
Experience:
- 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%.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.