DDReg Pharma Pvt. Ltd.

DDReg Pharma is a global life sciences consulting firm specializing in regulatory affairs, pharmacovigilance, and quality services. With over 15 years of experience, they help pharmaceutical, biotech, medical device, veterinary, food supplement, and cosmetic companies navigate complex regulatory landscapes. DDReg offers solutions for IPR, GMP compliance, toxicology, and utilizes technology-driven tools like RIMS and an AI-driven Regulatory Intelligence platform to expedite product registrations and ensure compliance throughout the product lifecycle. Their business model is based on providing expert consulting services and technology-enabled solutions to accelerate revenue growth for life sciences companies.

Drug SafetyGMP ComplianceIPRLife SciencesPharmacovigilanceRegTechRegulatory AffairsRegulatory Intelligenceddregpharma.com

DDReg Pharma Pvt. Ltd.

Drug SafetyGMP ComplianceIPRLife SciencesPharmacovigilanceRegTechRegulatory AffairsRegulatory Intelligenceddregpharma.com

HQGurgaon, IN

Team Size88

Open Jobs12

Total Funding-

Latest FundraiseUnknown

Join the Team

Senior Manager-Regulatory Affairs-EU/US_Onsite

On-SiteGurgaon, Haryana, IN

On-Site • Gurgaon, Haryana, IN

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Sr. Manager-Regulatory Affairs- US/EU

Experience: -15+ Years

Location: Gurgaon

We are looking for an experienced and accomplished Senior Manager – Regulatory Affairs (CMC) with deep expertise in US and EU regulatory frameworks . The role will drive regulatory strategy, dossier submissions, and lifecycle management activities across these key markets, ensuring compliance and regulatory excellence. The ideal candidate will bring 15+ years of proven experience in regulatory affairs, with a strong command of CMC regulations and a successful track record of managing complex global submissions.

Roles & Responsibilities

Education & Experience

Master’s degree in Pharmacy (Pharma) or a related field.
15+ years of regulatory affairs experience, with significant exposure to US and EU CMC submissions.

Knowledge, Skills & Abilities

In-depth knowledge of US FDA, EMA, and ICH CMC guidelines.
Strong ability to interpret and analyze complex technical and scientific data.
Exceptional oral and written communication skills, with strong presentation abilities.
Proven leadership and mentoring skills with a collaborative, results-driven style.
Excellent problem-solving and decision-making capabilities.
Proficiency with document management systems and Microsoft Office Suite (Word, PowerPoint, Excel, Outlook).
Ability to manage multiple priorities and deliver high-quality outputs under pressure.

Why Join Us?

Play a key leadership role in shaping regulatory strategies for high-priority US and EU markets.
Opportunity to lead impactful submissions and contribute to global product approvals.
Exposure to cross-functional teams and business strategies.
Work in a collaborative environment with a focus on innovation and regulatory excellence.

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