Syngene Hiring Regulatory Affairs Junior Manager – Apply Now

Syngene International Limited, a leading innovation-led contract research, development, and manufacturing organization, is seeking a talented Junior Manager for its Regulatory Affairs team in Bangalore. This is an exciting opportunity for professionals with expertise in CMC regulatory filings to contribute to a global leader in pharmaceutical and biotechnology services.

About Syngene

Syngene (www.syngeneintl.com) offers integrated scientific services, from early discovery to commercial supply. Known for its commitment to innovation, Syngene is driven by its mission to deliver quality solutions that positively impact healthcare globally. The company fosters a culture prioritizing safety, integrity, and excellence.

Location: Biocon SEZ, Biocon Park, Bommasandra Industrial Area, Jigani Link Road, Bengaluru, Karnataka 560099, India.

Role Overview: Junior Manager – Regulatory Affairs

As a Junior Manager in Regulatory Affairs, you will play a pivotal role in ensuring successful regulatory filings, registrations, and post-approval maintenance for various markets, including the US, Europe, and emerging regions. Your expertise will directly impact the availability of life-saving therapeutics for patients worldwide.

Key Responsibilities

• Provide comprehensive CMC Regulatory support for novel drugs and generics, including small molecules and biologics.
• Research and interpret regulatory requirements for new molecules or product categories.
• Prepare and submit eCTD dossiers, ensuring compliance with IND, NDA, ANDA, MAA, and other regulatory frameworks.
• Review and assess documentation such as development reports, specifications, and validation protocols.
• Maintain product marketing authorization renewals and update dossiers to comply with regulatory changes.
• Manage Regulatory Document Management Systems (RDMS), EDMS, and Quality Management Systems (QMS).
• Train team members in regulatory policies and develop SOPs to streamline operations.
• Collaborate with stakeholders and provide regulatory strategy inputs to clients.
• Uphold Syngene’s safety and quality standards, ensuring adherence to all EHS guidelines.

Qualifications and Experience

Education:

• B.Pharm / M.Pharm or a degree in Life Sciences.

Experience:

• 6 to 13 years of hands-on experience in CMC Regulatory Affairs for APIs or formulations (preferably injectables) in developed markets (US, Europe).
• Expertise in investigational medicinal products and marketing authorizations.
• Experience in biologics, ADC, or veterinary drugs is a plus.

Skills:

• Proficiency in eCTD submissions and familiarity with RDMS, EDMS, and QMS.
• Strong understanding of CMC processes for APIs and drug products.
• High-level proficiency in English (verbal and written communication).

Equal Opportunity Employer

Syngene is committed to fostering a diverse and inclusive workplace. The company ensures equal employment opportunities for all individuals, regardless of age, gender, race, religion, or disability. Reasonable accommodations are available for qualified individuals with disabilities.

Application Details

Interested candidates can apply for this position by visiting the official Syngene careers page:
Apply Here

Tagged as: EU Markets, Good Clinical Practice (GCP)