Chief Regulatory Officer

We are seeking an accomplished Senior General Manager to lead our Regulatory Affairs department. The ideal candidate will possess a strong understanding of regulatory requirements and procedures in India.

The successful candidate will be responsible for providing strategic regulatory guidance to cross-functional departments, coordinating with regulatory authorities and customers/consultants, and advising on regulatory submissions.

• Liaison with Regulatory Authorities: Coordinate with DGCI and India Regulatory bodies to ensure compliance with regulatory requirements.

• Regulatory Advice: Provide expert advice to cross-functional departments on regulatory matters, review and advise on regulatory documentation to ensure accuracy and completeness.

• Team Guidance: Guide the regulatory/quality team to perform their functions efficiently and accurately, identify team members' capabilities and assign additional responsibilities accordingly.

• Compliance and Audits: Facilitate preparation of compliance reports for GMP audit observations, guide cross-functional departments on implementation of systems for regulatory expectations and compliance.

• Technical Review: Review technical and investigation reports for adherence to regulatory guidelines, provide guidance to cross-functional technical teams on regulatory documentation requirements.

• Operational Evaluation: Evaluate day-to-day operational issues for regulatory implications, develop short-term and long-term mitigation measures to address regulatory concerns.

To succeed in this role, you should have a deep understanding of regulatory requirements and procedures in India. Additionally, you should possess excellent communication and interpersonal skills, be able to work effectively in a team environment, and have a proven track record of delivering results.