Pushpinder Singh
Director, Global Regulatory Affairs | Global Pharmaceutical & Drug-Device Combination Product Expert | IND, NDA, BLA, ANDA, 510(k) Submissions
- Role
- Director Global Regulatory Affairs Cmc at Organon
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Pushpinder Singh
Strategic Regulatory Affairs leader with extensive experience guiding early- and late-stage pharmaceutical and drug-device combination programs across global markets. Proven expertise in developing regulatory strategies, securing approvals, and ensuring compliance with FDA, EMA, ICH, and international standards. Demonstrated success in navigating complex regulatory landscapes, mitigating risks, and enabling timely market access for innovative therapies.Recognized for leading cross-functional teams, mentoring regulatory professionals, and fostering alignment between R&D, commercial, and manufacturing operations. Skilled in lifecycle management, pre-IND/IND planning, post-approval changes, and submissions for INDs, NDAs, BLAs, ANDAs, CTAs, MAAs, and 510(k) filings. Experienced in authoring regulatory strategy documents, developing authorizing guides, and implementing Right-First-Time submission practices.Committed to driving regulatory excellence and strategic value in fast-paced, highly regulated environments. Actively engaged with global health authorities to optimize regulatory pathways and support product development initiatives. Open to connecting with professionals and organizations seeking innovative, compliant, and efficient regulatory solutions for complex pharmaceutical and medical device portfolios.
Experience
Director Global Regulatory Affairs Cmc
Jan 2026 — Present · US
Education
National Institute of Pharmaceutical Education and Research (NIPER) ,SAS NAGAR , Mohali
MBA (Pharmaceutical Administration)
St. Edward's School, Shimla
High School Diploma
Guru Nanak Dev University, Amritsar
Bachelor's degree, Pharmacy
Skills
- Regulatory Requirements
- Anda
- Pharmacovigilance
- Ectd
- Pharmaceutical Industry
- Generic Programming
- Regulatory Affairs
- Regulatory Submissions
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