Ankur Agarwal

About Ankur Agarwal

M.Pharm, RAC, PGDIB and Six Sigma green belt with more than 17 years of experience in drug (including Oral dosage forms, injectables and nasal products) and medical device (including combination products) regulatory affairs and Quality assurance combined, interactions with regulatory health authorities/Notified bodies/industry representatives/clients with respect to different stages of development cycle for drugs/devices and team management.• Knowledge and skills to manage product development from regulatory aspects, obtaining marketing approvals from global market including EU & US and leading workforce towards accomplishing business goals.• Possess strong analytical skills to interpret regulatory and scientific guidelines as well as to negotiate with Health authorities, respond regulatory queries and obtain pre and post marketing approvals• Experienced in People management and technical management of regulatory teamsCore Competencies• To formulate, lead and communicate regulatory strategies for drugs (including Oral dosage forms, injectables and nasal products) and medical device (including combination products) to penetrate in EU, US and emerging market.• Liaise with relevant departments of R&D and Plant to manage product development from regulatory aspects and ensure that regulatory requirements for submissions are met.• Preparation and Submission of Market approval applications in EU (via MRP, DCP, NP and CP), US, Switzerland, GCC, South Africa and other emerging markets.• Post approval activities like preparation & submission of variations (Type IA, IB, II, grouped and worksharing in EU), MA transfer, duplicate MA, CPP and renewals/annual reports in EU/US and emerging markets.• Submission of Pediatric Investigational Plan (PIP) in EU.• Respond to queries raised by regulatory authorities.• Review CMC Documents like Specifications, PV, AMV, stability, Pharmaceutical development report etc.• People management and technical management of regulatory teams

Experience

1. Associate Director- Global Regulatory Science Cmc

   百时美施贵宝

   Nov 2024 — Present · Hyderabad, IN

   As a single point of accountability for Small Molecule Established and Mature Assets within Global Regulatory Sciences (CMC), I lead a centralised team responsible for the strategy, coordination, and execution of regulatory activities across the global Established Brands portfolio. This includes both drug products and drug–device combination products across all therapeutic areas.Key Responsibilities and Focus Areas:Lead and mentor a team of CMC leads that are responsible for lifecycle management, geo-expansions, compliance submissions, and regulatory maintenance across all markets.Develop and implement CMC strategies that ensure global compliance, business continuity, and timely delivery of regulatory dossiers.Oversee regulatory strategy, authoring and submission planning for the ongoing and upcoming INDs/CTAs and new regulatory submissions across the portfolio.Collaborate cross-functionally with quality, manufacturing, and supply chain teams to streamline regulatory operations and enable efficient implementation of post-approval changes.Drive simplification, digital enablement, and process harmonization to enhance speed and consistency in global submissions.Focus on leadership, coaching, and developing team capabilities to build a strong and future-ready CMC organization.

Education

• Lachu memorial college

  M.Pharm, Phamaceutical management and regulatory affairs

  2006 — 2008

• Ryan international school

  Secondary

  1997 — 1999

• DAV

  Senior Secondary

  1999 — 2001

• Maharishi Arvind College of Pharmacy

  B.Pharm

  2001 — 2006