Role Summary:
We are seeking a seasoned and strategic Chief Compliance Officer (CCO) to lead and strengthen our compliance framework within our rapidly growing pharmaceutical startup. The CCO will be responsible for developing, implementing, and overseeing all aspects of the company's compliance program, ensuring adherence to all applicable laws, regulations, and ethical standards in the pharmaceutical and life sciences sector in India and globally. This role is critical in fostering a culture of integrity and mitigating regulatory risks.

Key Responsibilities:

• Develop, implement, and maintain a comprehensive compliance program aligned with pharmaceutical industry regulations (e.g., CDSCO, FDA, EMA guidelines) and company policies.
• Oversee all regulatory affairs, including drug approvals, manufacturing licenses, and post-market surveillance.
• Establish and manage internal controls, policies, and procedures to prevent and detect compliance violations.
• Conduct regular compliance audits and risk assessments, identifying areas of potential vulnerability and implementing corrective actions.
• Provide guidance and training to employees on compliance matters, fostering a strong ethical culture.
• Manage investigations into alleged compliance breaches and recommend appropriate disciplinary actions.
• Stay abreast of evolving regulatory landscapes, industry best practices, and emerging compliance risks.
• Liaise with regulatory authorities, external auditors, and legal counsel on compliance-related matters.
• Ensure compliance with data privacy regulations (e.g., GDPR, Indian data protection laws) concerning patient and clinical trial data.
• Develop and manage the company's anti-bribery and anti-corruption policies and procedures.