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 Jobs27

Total Funding-

Latest FundraiseUnknown

Join the Team

Sr. Associate – RA _ Publishing _Gurugram (Onsite)

On-SiteGurgaon, Haryana, IN

On-Site • Gurgaon, Haryana, IN

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Job Descriptions

Provides regulatory publishing and submission support and oversight.
Publishes Regulatory documents with Docubridge software application for initial submissions as well as, routine/ maintenance submissions to support active applications such as supplements and periodic reports.
Trouble-shoots issues related to the published submissions.
Collaborate with submission content contributors, regulatory leads and project management in the planning and preparation of submission components.
Manage and execute assembly, publishing and timely submission of regulatory applications.
Provides guidance (and where necessary training) to Regulatory Affairs staff on all aspects of submission formats/requirements and publishing related software/tools as and when required.
Act as a Subject Matter Expert for publishing tools and standards.

Education & Experience

Bachelor’s degree in pharmacy, Life Sciences, Biotechnology, Chemistry, or related scientific field. A master’s or higher is preferred.
Hands‐on experience in publishing software (Lorenz is preferred) for submitting dossiers for US (FDA) and EU (EMA or national authorities).
Strong knowledge of eCTD and validation requirements.
Excellent written and spoken English; strong documentation skills.
Minimum 2-5 years of publishing experience, with substantial exposure to the validator tools.

Location Gurgaon, Haryana (Onsite) (INDIA)

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