Experience

Dr. Willmar Schwabe India Pvt. Ltd.

• India
• Alternative Medicine
• 100 - 200 Employee

• Sr Manager - Regulatory Affairs & Government Relations

  • Feb 2022 - Present

  Government Relations • Developed credibility with more than 60 bureaucrats including government officials, secretaries, directors, and Chairpersons of relevant task forces and working groups. • Align & engage with government (both central and state) to create good working relationships and adoption of portfolio products in public markets. Regulatory Affairs • Responsible for product registration, approvals, and renewals with FSSAI, CDSCO, state FDAs (UP and Haryana), DSIR (Department of Scientific and Industrial Research), Narcotics Control Bureau, Ayurvedic, Spices Board of India, and Export-Inspection Agency (EIA). • Assist in regulatory agency audits and inspections, and set up certifications for the facilities, including organic (NPOP, NOP), cGMP and food safety, HACCP, ISO-9001, 1400, Kosher and other appropriate licenses. • Assisting the site in achieving US-FDA recognition through the implementation of 21 CFR 117 and GMP. • Examine product labels and marketing materials to confirm that FSSAI, pharmaceuticals, Ayurveda, and homoeopathic products are in accordance with regulations. Project Management • Lead projects for phases III through IV and other Nutraceutical clinical studies; 3+ (Identifying and selecting CROs; negotiating the study budget and contract terms (NDA/CTA) and facilitating the start-up of the study. • Monitor and track patient enrollment and study progress from CRO. • Lead project (EU-GMP & US-FDA) - Identification and selection of regulatory agencies for the site’s preparation. Show less



SUN PHARMA

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manager - Corporate Affairs & Regulatory

  • Dec 2016 - Jan 2022

  Identify and build engagement and relationships with key stakeholders in all relevant Departments and Ministries, including DCGI, CDSCO-NZ, Ministry of Health and family welfare, Ministry of AYUSH, CCRAS, DBT, BIRAC, DSIR and CPCSEA. Apply a multi-level, multi-stakeholder approach in resolving operational matters including regulatory compliance & hurdles, product complaints, NSQ, online SUGAM portal, policy issues etc. Reviewed and submitted 70+ Technical Dossiers (NDAs, Clinical Trial Applications, CT & Bioequivalence & Bioavailability study waivers and Market Authorization) for approvals and registrations. Spearheaded projects: 25+ CT and BA/BE study waivers, 5+ First-to-file, 10+ Second to New Drugs or Subsequent New drugs, 2 COVID-19 drugs and 1 phytopharmaceutical COVID-19 drug. Developed credibility with 60+ bureaucrats including Govt. officials, Secretariats, Directors and Chairpersons of the relevant task forces. Policy advocacy and Policy analysis Identify emerging and significant policy issues and advocate the company's policy position. Representations on various policy issues e.g.- ‘Clarity on storage condition on the label of Pharmaceuticals products’ | Raised issue to revised ‘Simplified procedure on import, export of GE organisms for R&D purpose’ (Resolved, DBT notification Jan 17 2020). Ease of Doing Business - Raised issue to placing of ‘Oxytocin API’ from prohibited to restricted list to allow import (Resolved, Draft notification GSR 762(E), 27. 10. 2021) | Reduced ‘BA/BE studies (for export purpose) protocol fee’. Show less



National Institute Of Biologicals

• India
• Biotechnology Research
• 1 - 100 Employee

• Biologist

  • Nov 2012 - Dec 2016

  Reviewed and scrutinized dossiers of 50+ biological products for regulatory compliance. Prepared SOPs for sample storage and archiving. Facilitated analysis of drugs to find percentage spurious medicine cases in India’s biggest drug survey. 47K+ generic drugs samples | 654 districts | 224 drug molecules; 3.16% found to be NSQ & 0.2% spurious. Reviewed and scrutinized dossiers of 50+ biological products for regulatory compliance. Prepared SOPs for sample storage and archiving. Facilitated analysis of drugs to find percentage spurious medicine cases in India’s biggest drug survey. 47K+ generic drugs samples | 654 districts | 224 drug molecules; 3.16% found to be NSQ & 0.2% spurious.



Wockhardt Ltd.

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Buisness Executive

  • Apr 2011 - Nov 2012

  Successfully achieved 100% revenue target (INR 90 lakh) in Madhya Pradesh territory with 10% growth in 18 months. Collaborated with 80+ Doctors, 200+ pharmacies and 10+ Stockists. Spearheaded B2B sales: Jabalpur, defence (Army) hospital, 100+ healthcare Clinics & 6 corporate accounts (Medical colleges, Apollo and other Pvt. Hospitals). Successfully achieved 100% revenue target (INR 90 lakh) in Madhya Pradesh territory with 10% growth in 18 months. Collaborated with 80+ Doctors, 200+ pharmacies and 10+ Stockists. Spearheaded B2B sales: Jabalpur, defence (Army) hospital, 100+ healthcare Clinics & 6 corporate accounts (Medical colleges, Apollo and other Pvt. Hospitals).



Resilient Cosmeceuticals Pvt. Ltd.

• Indore Area, India

• Business Development Executive

  • Feb 2010 - Apr 2011

  Developed territories in MP (Indore, MHOW, Ujjain and Dhar) from zero business to 29L. Conducted 10+ CMEs in hospitals and launched products across different verticals. Conducted “Iron deficiency program” in hospitals and launched product to prevent pregnancy Anemia. Developed territories in MP (Indore, MHOW, Ujjain and Dhar) from zero business to 29L. Conducted 10+ CMEs in hospitals and launched products across different verticals. Conducted “Iron deficiency program” in hospitals and launched product to prevent pregnancy Anemia.