Hetero
Website:
hetero.com
Job details:
JD:
Liaise with Government departments and Regulatory Bodies including DGCA, CDSCO, International Cell, Department of Pharmaceuticals, Ministry of Health & Family Welfare, and other related agencies.
Coordinate with Indian and foreign embassies/high commissions for issuance of letters, endorsements, and support related to drug approvals, regulatory clearances, and international registrations.
Facilitate and follow up on drug approvals, manufacturing licenses, import/export permissions, NOCs, renewals, and statutory clearances.
Act as the point of contact between the organization and government bodies for all regulatory and policy-related matters.
Monitor changes in government policies, regulations, and guidelines impacting the pharmaceutical/healthcare sector and advise management accordingly.
Support regulatory teams in addressing queries, deficiencies, and compliance requirements raised by authorities.
Represent the organization in meetings, hearings, and official interactions with government officials and regulatory agencies.
Maintain strong professional relationships with key officials across departments to enable smooth and timely processing of applications.
Prepare, vet, and submit official correspondence, representations, and compliance reports to authorities.
Strong understanding of pharmaceutical regulations and government procedures.
Excellent liaison, negotiation, and interpersonal skills.
Ability to navigate complex bureaucratic processes effectively.
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