Regulatory Affairs Manager/Senior Manager
Enzene Biosciences Ltd
Summary
The Regulatory Affairs Manager is responsible for supporting the development, registration, approval, and lifecycle management of animal health products. The scope covers veterinary biologics regulated by the USDA Center for Veterinary Biologics (CVB) and FDA Center for Veterinary Medicine (CVM), with a primary focus on products under CVB jurisdiction.
Job description
Position Summary
The Regulatory Affairs Manager is responsible for supporting the development, registration, approval, and lifecycle management of animal health products. The scope covers veterinary biologics regulated by the USDA Center for Veterinary Biologics (CVB) and FDA Center for Veterinary Medicine (CVM), with a primary focus on products under CVB jurisdiction.
Candidates must have direct hands-on experience working with USDA CVB regulations and submissions for veterinary biologics and vaccines. Experience with FDA human pharmaceutical or biologics regulatory submissions and lifecycle management is highly desirable.
Key Responsibilities
Regulatory Strategy & Compliance
- Provide regulatory guidance to cross-functional teams including R&D, Quality, Manufacturing, Technical Services, and Commercial Operations.
- Assess regulatory risks and recommend strategies to ensure timely product development and approvals.
- Monitor evolving regulatory requirements and communicate their impact to internal stakeholders.
USDA CVB Responsibilities
- Author and implement applicable procedures to be in compliance with USDA CVB and FDA CVM requirements.
- Prepare, submit and manage regulatory filings to USDA CVB, including Product Licenses, Establishment License Document updates, Outline of Production submissions, Labeling approvals, Supplemental and amendment submissions, and Permits as needed.
- Coordinate responses to USDA questions and requests for information.
- Lead Inspection readiness for USDA inspections and compliance.
FDA CVM Responsibilities
- Lead submissions such as INADs (Investigation New Animal Drug), NADAs (New Animal Drug Application), CNADAs (conditional New Animal Drug Application), and supplement applications.
- Engage with CVM on technical, safety, efficacy and manufacturing issues.
- Inspection & Audit Support.
Working Conditions
- Flexible (Hybrid or remote) work options depending on location of the candidate and business needs. No relocation will be provided.
- Ability to travel up to 20-30% for agency meetings, inspections, audits, and industry conferences.
Requirements
- Bachelor's degree in veterinary medicine, Animal Science, Biology, Microbiology, Biotechnology, Regulatory Affairs, or related scientific discipline
- Minimum 5-8 years of regulatory affairs experience within animal health, veterinary biologics and vaccines
- Strong experience interacting with USDA Center for Veterinary Biologics (CVB) and with FDA Center for Veterinary Medicine (CVM)
- Demonstrated experience preparing and managing USDA regulatory submissions
- Strong understanding of product development, regulatory submissions, approvals, and lifecycle management
- Experience interacting directly with regulatory agencies and managing regulatory correspondence
- Excellent written and verbal communication skills
- Experience supporting regulatory inspections and compliance activities
Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- AD&D Insurance
- Disability Insurance
- 401(k) Retirement Plan
- Paid Time Off
Company overview
Enzene Biosciences Ltd is an integrated global Contract Development and Manufacturing Organization (CDMO) specializing in biologics and biosimilars development and production. Founded in 2008 and headquartered in Pune, India with operations in New Jersey, USA, the company offers comprehensive services spanning discovery, development, and commercial supply of biopharmaceutical products. Enzene's core innovation is its patented EnzeneX™ platform featuring Fully Connected Continuous Manufacturing (FCCM) technology, which has been validated for commercial biologics supply and demonstrates significantly increased production yields while reducing manufacturing costs. The company aims to lower monoclonal antibody production costs below $40 per gram by 2025, making biologics more accessible globally. Enzene operates multiple facilities including R&D centers in Bhosari, Pune, and a cGMP production facility in Chakan, Pune, with capabilities in mammalian cell culture, microbial fermentation, and drug product filling. The company serves clients across various therapeutic areas including biosimilars, phytopharma, peptides, and regenerative medicine, positioning itself as a technology-driven biotech company dedicated to enhancing global healthcare through disruptive innovation and cost-effective manufacturing solutions.