This late-stage biotechnology company is developing first-in class T Cell based cancer immunotherapies. They are seeking a Regulatory CMC Director who can contribute to global Regulatory CMC strategy and execution for their commercial biologic product. You will prepare and submit global post-approval CMC filings to global health authorities and work closely with cross-functional teams. This company offers innovative science, a patient-focused company culture, and the ability to work remotely. With their first rolling BLA in progress, now is an exciting time to join this innovative organization!
Responsibilities:
- Participate in the development of global CMC regulatory strategy and execution of post-approval filings for an approved biologic drug product.
- Manage and implement planning, preparation and submission of high-quality CMC filings in 13 countries.
- Actively seek out knowledge of overall corporate planning and other factors that affect the CMC regulatory positions taken within the company and incorporate this knowledge into submission planning.
- Exercise judgment on complex issues by interpreting product data against Health Authority requirements.
- Deliver high-quality CMC submissions by taking ownership of assigned submissions and then working with functions to align on submission content.
- Ensure CMC dossiers meet ICH format and content requirements, as well as the specific local requirements of individual Health Authorities.
- Build and manage relationships through active partnering with key internal and external stakeholders.
- Proactively identify risks to submission timelines and content.
- Stay current with regulatory requirements and initiate process improvements as appropriate.
Qualifications:
- Bachelors in a scientific discipline; advanced degree (MS, PhD, Pharm D) preferred.
- Ten or more years of experience in Regulatory CMC for pharmaceutical drugs and biologics.
- Post-approval Regulatory CMC experience with proteins and monoclonal antibodies highly preferred.
- Demonstrated track record of successful CMC submissions to FDA and other health authorities.
- Must have strong global/international Regulatory CMC filing experience (EMA, Health Canada, Asia Pacific, etc).
- Experience in post-approval dossier life cycle management and direct interactions supporting health authority GMP inspections desirable.
- Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
- Strong organizational and planning skills along with outstanding written and verbal communication skills.
- Proven ability to communicate effectively and efficiently cross functionally and with regulatory agencies.
- Ability to build positive relationships with co-workers of various backgrounds and expertise.
- Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.
- Must be comfortable with ambiguity within an evolving company.
The budgeted salary range for this position is $210,000 to $240,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.