Nagarjuna Akula

About Nagarjuna Akula

More than 2 decades of industrial experience covering Biopharmaceutical, Pharmaceutical, Vaccines drug substance and drug product manufacturing. Worked, stetted-up, led Quality control, Quality assurance and regulatory functions for wide range of products like sterile injectables, oral dosage forms, active pharmaceutical ingredients and Human vaccines with the customer centric focus and industrial experience. Experienced and Proven industry thought leader and Organizational transformation expert catalyzing Quality culture as a comitative advantage to enable sustainable business and deliver quality products to the patients needed. Made a quality management system sustainable and robust by transforming sites from use of manual system to Digital tools and Modules. Excellent in steering and building an effective Quality & Regulatory team from ground up as well as improving organizational capability. Skilled in influencing decision-making at senior executive level while forging strong partnerships and trust across functions and geographies to deliver business results. Instrumental in interpretation of regulatory guidelines/change notification and convention at site leadership. Astute at devising and executing high level business growth strategies and cost-effective strategies to increase profitability. Administered regulatory inspections includes – USFDA, EMA, ANVISA, SAHPRA, NPRA, WHO, COFEPRIS, ANSM, ISO, DCGI and responding to regulatory observations/483s and presenting to the authorities. Proficient in influencing positively the cross-functional teams, senior leadership, and key stakeholders to drive company performance. Articulate communicator having excellent problem solving, analytical and decision-making skills with keen attention to detail. Sensitive to multicultural and multinational environments and keep high level networking in a complex and matrix structure. Flexible to adapt and lead change and drive performance improvement through positive influence. Knowledge of crafting individuals’ objectives in line with organizational goals and strategy. Project management professional with a broad background in drug development working across multiple therapeutic areas within the pharmaceutical and Biotechnology industry.

Experience

1. Head -quality Operations & Regulatory Affairs

   Bharat Biotech

   Oct 2020 — Present · IN

   Direct overall aspects of quality & regulatory and EHS to provide leadership, direction, and guidance for Bharat Biotech group of companies Oversee continual improvements overall quality and compliance enhancement. Deliver exceptional support to the team members in launching of Covid-19 vaccine (COVAXIN) and other products. Lead overall team of ~350 and company total workforce

Education

• Jawaharlal Nehru Technological University

  Masters Degree in Science, , Chemistry

• Jawaharlal Nehru Technological University

  Ph.D, Chemistry

• Andhra University

  Bachelor's Degree in Science, Bio Chemistry