Pharma Regulatory Affairs at Dr. Reddy’s! Apply Now
Analyst Regulatory Affairs
Hyderabad, Telangana, India
Job Summary
We are seeking a detail-oriented Analyst in Regulatory Affairs to oversee Emerging Markets procedures in Russia, CIS markets to handle Marketing Authorization Application, and ensure compliance with regulatory guidelines. Responsibilities include managing chemistry, manufacturing, and controls (CMC) documentation, addressing deficiency letters, contributing to regulatory strategy development, and facilitating effective communication with stakeholders for successful product launches and regulatory compliance.
Roles & Responsibilities
- You will be responsible for preparation, review, and submission of Dossier in various Emerging Markets as per the applicable regulatory guidance in Emerging Markets.
- You will be 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.
- You will be responsible for reviewing critical quality/regulatory documents like specifications, stability protocols, stability data, development reports, justification reports, etc.
- You will be responsible for on-time responses to deficiency letters.
- You will be responsible for preparing Regulatory Strategy Notes, regulatory due diligence, and gap analysis for leverage products. Evaluating and sharing the Regulatory Affairs requirements with product development teams at the product introduction stage, performing regulatory due diligence and consolidated gap analysis for leveraging.
- You will be responsible for providing inputs at every stage of development of the product.
- You will be responsible for identifying all open issues and anticipated questions on regulatory submission at the respective stage of product development, Dossier filing, and deficiency responses in consultation with team leads.
- You will be responsible for reviewing and closing change control notifications (CCs) for under-development, under-review, and launch products in consultation with the team lead.
- You will be responsible for interacting with internal and external stakeholders/customers and providing timely regulatory guidance on various issues.
Qualifications
Educational Qualification: M Pharm in Pharma
Minimum Work Experience: 3-6 years of experience in Regulatory Affairs
Skills & Attributes
Technical Skills
- Knowledge of regulatory requirements of all geographies.
- Understanding of product development, manufacturing processes, Intellectual Property, and quality.
- Experience in GxP documentation, computer system validation (CSV).
- Experience in incoming, outgoing, and product quality.
Behavioral Skills
- Excellent communication and interpersonal skills.
- Efficient collaborator.
- Strong analytical and problem-solving abilities.
Link to apply: APPLY ONLINE HERE
Keywords: Dr. Reddy’s, Analyst Regulatory Affairs, Regulatory Affairs job, Hyderabad, Telangana, India, M Pharm in Pharma, Regulatory affairs experience, healthcare sector, pharmaceutical industry. Pharma Regulatory Affairs at Dr. Reddy’s! Apply Now. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.