Job Descriptions CMC review of technical documentation for regulatory filings to various markets – market: US- Gap Analysis and Remediation for module 3 -CMC

Development and implementation of regulatory strategies, processes and timelines for grant of ANDAs.

Prepares and compiles new ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.

Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.

Demonstrate subject matter and area expertise.

Collaborate with internal and external clients,

Supporting and enabling effective and efficient communication that results in operational excellence.

Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.

Education & Experience Master’s degree in Pharma

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 to 6 years’) or equivalent combination of education, training, & experience. Knowledge, Skills And Abilities Excellent technical data interpretation skills

Excellent interpersonal skills including problem solving

Excellent oral and written communication skills with strong presentation skills

Significant knowledge of US Regulations

Excellent computer skills; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)

Ability and desire to work in a team-oriented environment.





Excellent written and verbal communication skills

Highly proficient with Microsoft Word, PowerPoint and Excel.

Possesses a collaborative, results-driven style.

Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines Other Requirements As may be required from time to time – the incumbent may be required to working slots catering to different time zones Location Gurgaon, Haryana (INDIA) Related Sr. Associate/Associate – Regulatory Affairs – US Job Descriptions CMC review of technical documentation for regulatory filings to various markets – market: US- Gap Analysis and Remediation for module 3 -CMC Development and implementation of regulatory strategies, processes and timelines for grant of ANDAs. Prepares and compiles recent ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) filings… Manager-Regulatory Affairs_ GCC _Onsite (GGN) Job Descriptions CMC review of technical documentation for regulatory filings to various markets.

Development and implementation of regulatory strategies, processes and timelines for grant of MA- Africas, GCC, LATAM, ASEAN. Review of CTD dossiers , variations, change controls, renewals and ensuring that they are in conformance with applicable regulatory guidelines… Manager – Regulatory Affairs – EU_ Onsite Job Title: Assistant Manager – Regulatory Affairs (EU & UK)Location: Gurgaon, Haryana (India)Experience: 4–6 YearsQualification: Master’s Degree in Pharmacy (M.Pharm or equivalent) Role OverviewWe are seeking a proactive and detail-oriented Assistant Manager – Regulatory Affairs to join our Global Regulatory team. The ideal candidate will be responsible for driving CMC documentation,…

📌 Sr. Associate/Associate – Regulatory Affairs – US (Gurugram)
🏢 DDReg Pharma
📍 Gurugram