Sr. Associate/Associate – Regulatory Affairs – US

DDReg Pharma Inc; Gurugram District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

DDReg Pharma Inc in Gurgaon, Haryana, is seeking an Assistant Manager – Regulatory Affairs (EU & UK) to join the Global Regulatory team. You will drive CMC documentation and coordinate regulatory submissions across markets.

Requirements include a Master’s Degree in Pharmacy and 4–6 years of relevant regulatory experience, with strong knowledge of US regulations and excellent written and verbal communication.

Qualifications

• Master’s degree in Pharmacy required.
• 4–6 years of regulatory experience.
• Strong knowledge of US regulations and global filings.
• Excellent written and verbal communication skills.

Responsibilities

• CMC documentation review and compilation for regulatory filings.
• Develop regulatory strategies and manage timelines for submissions.
• Collaborate with internal and external stakeholders to ensure compliance.

Skills

Technical data interpretation

Problem solving

Oral and written communication

US Regulations knowledge

Microsoft Office

Education

Master’s degree in Pharmacy (M.Pharm)

Tools

Excel

PowerPoint

Word

Outlook

Job description

• 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

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…

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…

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,…