Divya Vohra

• Regulatory Affairs & Quality Assurance Professional with a Master’s in Pharmaceutics and BQS certification in ISO 9001:2015.
• Proficient in ISO 9001:2015 & ISO 15189:2012, with experience as an internal auditor.
• 10+ years of experience in regulatory approvals, compliance, and quality management across US, EU, and ANVISA markets.
• Regulatory Submissions & Documentation: Managed submissions for US, EU, ANVISA, and other markets, ensuring compliance with regulatory guidelines.
• Expert in regulatory documentation management, ensuring compliance with SOPs and regulatory guidelines.
• Project Management & Organization: Skilled in prioritizing and managing multiple projects to meet strict deadlines.
• Attention to Detail & Problem-Solving: Ensures accuracy in regulatory documentation and resolves compliance challenges effectively.
• Communication & Interpersonal Skills: Strong verbal and written communication for collaboration across departments and regulatory agencies.
• Process Improvement & Efficiency: Implemented strategies leading to a 20% increase in operational efficiency.
• Effective communicator & problem solver, ensuring seamless collaboration across departments.
• Proactive, action and detail-oriented, and committed to continuous learning and regulatory excellence, Quick learner and capable of multitasking in dynamic work environments.
• Ensures regulatory compliance & strategy alignment for product availability in target markets.
• Cross-Functional Collaboration: Works closely with sales, marketing, and regulatory teams to synchronize strategies and timelines for product availability.

1. Industrial Awards:

• Recognized for Excellence: Awarded the Spot Light Award three times (2019, 2021, 2023) by Bio-Rad Laboratories (India) Pvt. Ltd. for outstanding contributions, including the successful implementation of SAP for the India office.
• Reliable Backbone Support: Honored with the HO Support Award (2020) for providing exceptional back-end support to all India offices.
• Performance & Team Excellence: Recipient of the Star Performer Awardand Best Team Award twice (2017, 2018) at Gowrie Healthcare Pvt. Ltd. for dedication, enthusiasm, and impactful contributions to India’s Money-Making/Saving Scheme.
• Outstanding Contribution: Awarded a Certificate of Outstanding Contribution (2016) by BDR Pharmaceuticals Pvt. Ltd. for significant achievements and commitment to excellence.

2. Curricular:

• Recipient of Shri Ratan Tata Scholarship during B. Pharma

• Attended IPC -2009 and 2011, Pharmafest-2009 and 2012, Pharmavista-2009 and Pharmaescapade- 2010.
• Participated in Pharmacy Youth Essay Contest-2009, organised by International Journal of Pharmaceutical Research.
• Also Attended various national and international conferences at state and India level related to Advances in Drug Delivery Technologies, Nanomaterials and Particle Technology and Drug Discovery.
• Industrial visits to Dhanvantri Honey Manufacturing Units at Por, Vasu Pharmaceutical, Vadodara, Kaptab Pharmaceuticals, Vadodara, and Divine Laboratories, Vadodara.
• Received Certificates for Participating & Organizing Various Events at the College level.

• Expertise in global regulatory compliance, including 21 CFR, EU MDR, IVDR, USFDA, CDSCO, and BIS.
• Skilled in product registration, renewals, and regulatory documentation across EMEA and other markets.
• Proficient in SAP ERP, PIMS, CHIMS, SIMS, SIP, and EPR for regulatory operations.
• Strong background in quality management, auditing, and compliance with industry standards.
• Leadership in team management, coaching, and cross-functional collaboration in multicultural environments.
• Strategic thinker with strong planning, critical thinking, and decision-making abilities.
• Effective communicator with exceptional interpersonal skills and a proactive approach.
• Experienced in customs regulations, operations, and project management, leveraging Six Sigma methodologies.
• Adapt at time and performance management, ensuring efficiency under strict deadlines.

• Date of Birth: 03/20/88
• Gender: Female
• Nationality: Indian
• Marital Status: Married

• Recognized for Excellence, Awarded the Spot Light Award three times (2019, 2021, 2023) by Bio-Rad Laboratories (India) Pvt. Ltd. for outstanding contributions, including the successful implementation of SAP for the India office.
• Reliable Backbone Support, Honored with the HO Support Award (2020) for providing exceptional back-end support to all India offices.
• Performance & Team Excellence, Recipient of the Star Performer Award and Best Team Award twice (2017, 2018) at Gowrie Healthcare Pvt. Ltd. for dedication, enthusiasm, and impactful contributions to India’s Money-Making/Saving Scheme.
• Outstanding Contribution, Awarded a Certificate of Outstanding Contribution (2016) by BDR Pharmaceuticals Pvt. Ltd. for significant achievements and commitment to excellence.
• Curricular, Recipient of Shri Ratan Tata Scholarship during B. Pharma

• Quality Management System Certification (ISO 9001:2015) by BQS Quality services
• Current regulatory requirements for conducting clinical trials in India for investigational new drugs and new drug (Version 3.0)

OBJECTIVE:

• Aspiring to excel as an RAQA professional in a dynamic organization where I can leverage my expertise to drive regulatory compliance, uphold the highest quality standards, and contribute to business success. With a strong work ethic, determination, and a commitment to continuous learning, I strive to enhance my skills and make a meaningful impact in the industry.

AREAS OF INTEREST:

• I have a keen interest in medical devices and IVD, with experience in QMS system maintenance, SOP preparation, and regulatory compliance.
• My background includes managing QMS and regulatory activities for MD and IVD industry, corporate quality assurance and regulatory affairs for drugs and formulations in regulated and non- regulated markets, formulation development, regulatory filings, and pharmacovigilance document management.