Subham Kumar Singh Email & Phone Number

As a Regulatory Affairs Officer at Lincoln Pharmaceuticals Limited, I specialize in ensuring that our pharmaceutical products meet all regulatory requirements in global markets. My role involves navigating the complex regulatory landscape to facilitate the commercialization of safe and effective drugs. With a strong foundation in both regulatory affairs and drug development, I collaborate with cross-functional teams to ensure timely product approvals and compliance with international health authorities.Key Responsibilities:■- Regulatory Submissions: Prepare and compile regulatory submissions such as Drug Master Files (DMF), Dossiers, and Product Registration Applications for submission to regulatory authorities ■- Compliance Monitoring: Ensure all products and processes comply with the latest regulatory guidelines, including ICH, FDA, EMA, and other regional health authorities.■- Document Management: Handle the preparation, review, and submission of essential regulatory documents, including Quality Information Summary (QIS), Quality Overall Summary (QOS), and other technical files.■- Regulatory Strategy: Develop regulatory strategies to optimize submission timelines and support the company’s expansion into new markets.- Liaison with Authorities:Act as the point of contact with regulatory agencies, addressing inquiries, deficiencies, and maintaining an open line of communication to ensure smooth approval processes.■- Post-Approval Maintenance: Manage post-approval activities, including variations, renewals, and periodic updates to maintain product licenses in compliance with evolving regulations.■- Internal Collaboration: Work closely with R&D, Quality Assurance, and Business Development teams to provide regulatory guidance and ensure compliance throughout the product lifecycle.I am passionate about ensuring the quality and safety of healthcare products while supporting the company’s mission of bringing innovative and affordable pharmaceutical solutions to the global market.

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  Career Point University Kota

  A+