Regulatory Policy and Government Affairs - Assistant Manager

Role & responsibilities

At least 3 to 5 years of relevant experience in regulatory affairs, government relations,
compliance, or public policy, preferably in the pharmaceutical / biotechnology services industry or with a government regulatory body like the CDSCO, FDA or EMA.

• In-depth knowledge of global and India's regulatory environment and policy landscape, as well as the key stakeholders and decision-makers in the government and industry.
• Monitor and analyse government policies, legislation, regulations, and industry trends that
  impact the pharmaceutical and biotechnology sectors in globally and in India. The liaison will assist in providing timely updates and recommendations to senior management.
• Develop and execute a comprehensive regulatory policy and government affairs strategy to
  support the Biocon Biologics objectives and growth plans.
• Work closely with the section head / global head on BBL efforts in regulatory policy in the CDSCO US, EU and other emerging markets.
• Act as a liaison between the organization and state, local, federal, and international agencies
  and facilitate third-party activities as necessary.
• Explore for relevant nomination activities for suitable award category in Pharmaceutical and Biotechnological associations / government category, public speaking opportunities and assist in drafting / authoring policy publications in support of biosimilars.
• Work closely with QA teams and lead efforts in regulatory compliance in manufacturing sites.
• Work closely with the CQC team and extend process improvement and audit preparedness
  for the development function across R&D, CDMA, and Pharmacovigilance.
• Work on special projects based on using technology to bring efficiencies in the department.
• Strong analytical, problem-solving, and strategic thinking skills, with the ability to interpret
  complex regulatory guidance / policies and other regulatory documents to provide clear and concise guidance and advice to senior management.