Senior Scientist, Regulatory CMC (Biotechnology)

Location: On-site in Summit, New Jersey, United States. Monday–Friday during standard business hours, with flexibility available with manager approval.

Annual base pay: $140,000–$154,000, plus eligibility for a discretionary bonus and equity award.

Company

A commercial-stage biotechnology company developing cell and immunotherapy products, vaccines, and other therapies designed to harness and amplify the immune system against cancer and infectious diseases.

What you will do

• Prepare and review CTD Module 2 Quality Overall Summaries and Module 3 documents according to regulatory guidance and internal standards.
• Support global CMC regulatory strategies for investigational and marketed products, including lifecycle management.
• Prepare and review pharmacy manuals, protocols, CMC reports, and other submission documentation.
• Collaborate with CMC subject matter experts and cross-functional teams on regulatory requirements and CMC topics.
• Support the design of CMC protocols and prepare responses to Health Authority comments and questions.
• Train colleagues on Regulatory Affairs SOPs, document processes, templates, quality control, and application preparation when appropriate.

Requirements

• Bachelor’s degree in life sciences or a technical discipline with 6+ years of relevant progressive experience; or a master’s degree with 4+ years; or a doctorate with 2+ years.
• Experience preparing CMC module submissions in eCTD format.
• Familiarity with organizing responses to Health Authority requests and with CMC guidance documents and requirements.
• Knowledge of Health Authority procedures for document management and electronic submissions.
• Proficiency with Electronic Document Management Systems and strong organizational, written, oral communication, and attention-to-detail skills.
• Ability to work on site in Summit, New Jersey and meet firm deadlines while adapting to changing priorities.

Nice to have

• Experience with regulatory submissions outside the United States.
• Knowledge of biologic-based drugs, including cell-based therapies, gene therapies, antibodies, and recombinant proteins.

Culture & Benefits

• Collaborative work across scientific and functional areas on project teams.
• Professional development opportunities within a growing publicly traded biopharmaceutical company.
• Medical, dental, and vision plan options, health and financial wellness programs, and an Employee Assistance Program.
• Life and disability insurance, flexible spending accounts, a 401(k) plan with company match, and a 529 education savings program.
• Paid time off, holidays, legal services, identity theft protection, pet insurance, and employee discounts and rewards.