Senior Associate/Associate – Regulatory Affairs – US
DDReg Pharma Pvt. Ltd.Role Overview
DDReg Pharma Pvt. Ltd. is hiring a Senior Associate/Associate – Regulatory Affairs – US. This is a full-time role in Gurugram. Full responsibilities, required qualifications, and the apply link are listed in the description below.
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Job Description
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
Frequently Asked Questions
How do I apply for the Senior Associate/Associate – Regulatory Affairs – US position at DDReg Pharma Pvt. Ltd.?
Use the Apply button above to submit your application directly to DDReg Pharma Pvt. Ltd.. Most applications take less than 5 minutes if your resume and contact details are ready, and you'll be routed to the employer's official application system to finish.
Where is the Senior Associate/Associate – Regulatory Affairs – US position at DDReg Pharma Pvt. Ltd. located?
This position is based in Gurugram. DDReg Pharma Pvt. Ltd. has not indicated remote or hybrid options for this role, so candidates should plan for on-site work.
What does a Senior Associate/Associate – Regulatory Affairs – US at DDReg Pharma Pvt. Ltd. earn?
DDReg Pharma Pvt. Ltd. has not disclosed a salary range in this posting. Many employers share specifics later in the interview process; you can also ask during a recruiter screen if compensation transparency is important to you.
When was the Senior Associate/Associate – Regulatory Affairs – US role at DDReg Pharma Pvt. Ltd. posted?
This role was posted on April 14, 2026 (67 days ago). It's still listed as actively hiring; we re-confirm openings against the source system multiple times per day and remove closed roles.
How much experience does the Senior Associate/Associate – Regulatory Affairs – US role at DDReg Pharma Pvt. Ltd. require?
This is a senior-level position. Most senior roles call for 5+ years of directly relevant experience. DDReg Pharma Pvt. Ltd. lists their specific requirements in the description below, so review the must-have qualifications closely before applying.
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