Regulatory Affairs Specialist Jobs at Dr. Reddy’s Laboratories | Chemistry Candidates Apply
Dr. Reddy’s Laboratories, a trusted name in global pharmaceuticals, is hiring a Regulatory Affairs Specialist in Hyderabad. The position focuses on Oligonucleotide-based products, regulatory compliance, and DMF submissions across international markets. This is an excellent opportunity for professionals passionate about pharmaceutical innovation and compliance to join a company committed to quality, ethics, and advancing healthcare worldwide.
Job Summary:
We are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides. This role involves ensuring compliance with regulatory requirements for these products. Responsibilities include managing chemistry, manufacturing, and controls (CMC) documentation for DMF submission, addressing deficiency letters, contributing to regulatory strategy development, and facilitating effective communication with stakeholders for successful product approvals, launches, and regulatory compliance.
Roles & Responsibilities:
- DMF Submission and Management: You will be primarily responsible for handling the new DMF submission, lifecycle management globally for Oligonucleotide products.
- Regulatory Compliance: Ensure that all Oligonucleotide products comply with local, national, and international regulations and guidelines.
- Interface and Guidance: You will act as the primary interface between the technical teams and regulatory function and will be responsible to direct technical writing teams on ensuring alignment with the requirements & regulatory needs for Oligonucleotides.
- Knowledge of Regulatory Procedures: You should have knowledge of US submission procedures, European registration procedures, and regulatory submission procedures globally.
- Drug Master Files Preparation: Responsible for preparation, review, and submission of Drug Master Files for all regulated and non-regulated markets as per the applicable regulatory guidance.
- Documentation Authoring: Responsible for authoring high-quality chemistry, manufacturing, and controls (CMC) documentation for health authorities’ submissions, applying agreed CMC global regulatory strategies, assuring technical congruency, and regulatory compliance throughout the project lifecycle for Oligonucleotides.
- Regulatory Files Maintenance: Maintain and update regulatory files, including submissions, approvals, and renewals.
- Collaboration: Collaborate with cross-functional teams to gather necessary documentation and information for regulatory submissions.
- Review and Quality Control: Review of critical quality/regulatory documents like specifications, controls strategy for impurities, stability data, development report as per Quality by Design (QbD) requirements, justification reports, etc.
- Deficiency Letters Response: Responsible for on-time Response to deficiency letters.
- Regulatory Strategy Development: Prepare Regulatory strategy notes, conduct regulatory due diligence and gap analysis for leverage products.
- Regulatory Communication: Responsible for Communication/ Correspondence with regulatory Health authorities for the preparation and review of Scientific advice meeting packages.
- Issue Identification: Identifying all open issues and anticipated questions on regulatory submission at respective stages of product development, DMF filing, and deficiency responses in consultation with team leads.
- Change Control Notifications: Review and closure of change control notifications (CRNs) for under development, under review, and launch products in consultation with the team lead.
- Launch Support: Provide launch support with regard to key regulatory decisions.
- Regulatory Compliance Assurance: Ensure regulatory compliance of drug products by meeting current regulatory agency requirements.
- Stakeholder Interaction: Interact with Internal and External stakeholders/customers and provide timely regulatory guidance on various issues.
- Global Correspondence: Correspond with the Agency globally to understand the specific regulatory requirements for Oligonucleotides.
