Syngene International Limited (www.syngeneintl.com) is a leading innovation-driven contract research, development, and manufacturing organization. Headquartered at Biocon Park, Bangalore, Syngene delivers integrated scientific services, supporting clients from early discovery to commercial supply. With a strong focus on safety, integrity, and quality, Syngene stands as a trusted partner for pharmaceutical, biotechnology, and healthcare companies globally.
Syngene ensures a safety-first culture by prioritizing environment, health, and safety (EHS) measures across all operations. Every team member is accountable for maintaining a safe workplace and adhering to stringent safety protocols.
Job Title:
Junior Manager – Regulatory Affairs
Job Location:
Syngene International Limited, Biocon SEZ, Biocon Park, Plot No. 2, 3, 4 & 5, Bommasandra Industrial Area, Jigani Link Road, Bengaluru, Karnataka 560099, India.
Core Purpose of the Role
The Junior Manager – Regulatory Affairs plays a crucial role in supporting regulatory submissions for novel drugs and generics, including small molecules and biologics. The role focuses on compiling, authoring, and filing eCTD dossiers, ensuring compliance with regulatory standards for developed and emerging markets.
Responsibilities in the Job
The key accountabilities for the Junior Manager – Regulatory Affairs role include:
- Regulatory Submissions and Filings
- Provide critical CMC regulatory support for novel drugs and generics across development and lifecycle stages.
- Lead the preparation, review, and timely submission of IND, NDA, MAA, ANDA, and DMF dossiers.
- Compile, author, and publish eCTD regulatory filings.
- Document Review and Assessment
- Review plant and R&D documents like development reports, BMR, BPR, specifications, and validation reports.
- Conduct regulatory assessments, identify risks, and propose corrective measures.
- Regulatory Strategy and Project Management
- Research and analyze regulatory requirements for new molecules/products based on business needs.
- Provide regulatory strategy inputs to internal teams and clients.
- Manage marketing authorization renewals and maintain updated product dossiers.
- Quality and Compliance
- Maintain Quality Agreement trackers and review new Quality Agreements.
- Ensure adherence to Syngene’s quality standards, regulatory guidelines, and data integrity protocols.
- Training and Safety
- Train staff on regulatory policies and procedures.
- Participate in EHS training programs and uphold workplace safety.
Qualifications Required
To be eligible for the Junior Manager – Regulatory Affairs role, candidates must meet the following qualifications:
- Education:
B.Pharm / M.Pharm / Life Sciences degree. - Experience:
- 6 to 13 years of experience in CMC Regulatory Affairs.
- Expertise in small molecule APIs, formulations (injectables preferred), and marketing authorization for US, Europe, or developed markets.
- Experience with investigational medicinal products.
- Exposure to biologics, ADCs, or veterinary drugs is a plus.
Skills and Competencies
The ideal candidate should possess the following skills:
- Proficiency in eCTD submissions and hands-on experience with RDMS, EDMS, and QMS systems.
- Strong understanding of CMC (API and Drug Product) regulatory requirements.
- Excellent communication skills in English (reading, writing, and speaking).
- Proven ability to perform regulatory interpretations and ensure compliance.
