Regulatory Affairs CMC Lead - Biologics & Small Molecules

Kaztronix; Pennsylvania; On-site; USD 120,000 - 170,000; Full time

Job summary

Kaztronix is seeking a Senior Manager, Regulatory Affairs, CMC to lead regulatory strategy and submissions for biologics and small molecules from development through post-approval.

The role requires 3-5 years in regulatory CMC, with strong biologics experience and familiarity with global filings, eCTD submissions, and document management systems (Veeva Vault). Excellent cross-functional collaboration and communication with health authorities are essential for program success.

Qualifications

• BA/BS in a scientific field is required.
• 3-5 years in regulatory affairs CMC; biologics experience highly desirable.
• Experience with eCTD submissions and global filings.
• Knowledge of pharmaceutical drug development and CMC regulations.

Responsibilities

• Lead regulatory CMC strategy and submissions for biologic/small molecule programs.
• Review CMC data packages to support clinical trials and marketing applications.
• Ensure submissions meet current regulatory standards; maintain high quality.
• Coordinate pre- and post-approval activities (change control, variations).
• Liaise with FDA and health authorities; prepare and summarize meetings.
• Keep up-to-date with US/international guidance affecting CMC.

Skills

Regulatory CMC experience

Biologics knowledge

Global regulatory filings

Cross-functional collaboration

Education

BA/BS in a scientific field

Advanced degree in regulatory affairs/biological sciences

Tools

Veeva Vault

Starting Point templates

Microsoft Word Templates

eCTD submissions

Electronic document management systems

Job description

Job Summary (Primary function)
The Senior Manager, Regulatory Affairs, CMC will primarily be responsible for managing regulatory CMC submissions and strategy for development and marketed products, for biologic/small molecules, from early development through late-stage (phase 3, registration and post-approval). Extensive experience in biologics preferred.

Essential Functions of the Job (Key responsibilities)
• Ensures regulatory guidance documents and laws, as well as internal policies and procedures, are followed to ensure regulatory compliance is maintained.
• In alignment with RA-CMC leader, manages regulatory CMC strategy and submission aspects for biologic/ small molecule development programs.
• Provides critical review of the CMC data packages from other functional team representatives to support clinical trial and marketing applications.
• Ensures regulatory CMC submissions comply with current regulatory standards, are of high quality, consistent and complete.
• Participates in and manages pre- and post-approval global product activities such as, but not limited to, change control, and marketing application supplements and variations.
• Works with CMC functional experts to provide timely responses to CMC regulatory questions from global health authorities.
• Participates in meetings with internal and external partners or teams for clinical development programs or collaborations, in order to communicate regulatory CMC guidance and strategies.
• Support RA-CMC leader by liaising with FDA and other health authorities as needed (e.g. telephone contacts, submissions). Support RA-CMC leader with preparation for regulatory CMC related health authority meetings for assigned projects. Help prepare summaries of meetings and contacts for inclusion in the regulatory archives.
• Maintains current knowledge of relevant US and international guidance, laws and regulations, and proposed and final rules which affect CMC pharmaceutical drug development.

Qualifications (Minimal acceptable level of education, work experience, and competencies)
• BA/BS degree is required in a scientific field. Advanced degree (M.S., Ph.D. or Pharm.D.) in biological sciences (biochemistry, biotechnology, or microbiology), regulatory affairs, or related pharmaceutical field preferred.
• A minimum of 3-5 years of experience in regulatory affairs CMC or a related pharmaceutical development field. Experience with regulatory CMC aspects of biologic/large molecule drugs (monoclonal and bispecific antibodies) highly desirable. Additional experience in small molecules is a plus. Experience with global clinical trial and marketing applications, eCTD submissions, electronic document management systems (e.g., Veeva Vault platform), and Starting Point and Microsoft Word Templates.
• In-depth knowledge of pharmaceutical drug development, and CMC regulations/ guidelines governing development of pharmaceuticals and/or biotechnology products.


Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.