Compliance and Regulatory Head

Urgently Required

Compliance and Regulatory Head

Experience :  1 to 5 years

No of vacancies :  1

Job Description: The Compliance and Regulatory Head is responsible for ensuring that the organization adheres to all pharmaceutical regulations, ethical standards, and internal policies. This role involves developing regulatory strategies, managing compliance programs, overseeing regulatory submissions, and maintaining relationships with regulatory authorities to ensure product approvals and organizational integrity.

Key Responsibilities: Regulatory Strategy: Develop and implement regulatory strategies to ensure compliance with domestic and international regulations (e.g., CDSCO, USFDA, EMA, WHO-GMP).
Compliance Management: Design, implement, and monitor compliance programs to mitigate regulatory risks and ensure adherence to industry standards.
Regulatory Submissions: Oversee the preparation and submission of regulatory dossiers, including NDAs, ANDAs, and DMFs.
Audit and Inspection Readiness: Lead the organization’s preparation for regulatory inspections and audits, ensuring full compliance with guidelines.
Cross-Functional Collaboration: Work closely with R&D, manufacturing, quality, and legal teams to align regulatory and compliance efforts.
Policy Development: Establish and enforce internal policies to ensure adherence to ethical standards and regulatory requirements.
Training and Awareness: Conduct training programs for employees to ensure awareness of compliance standards and regulatory updates.
Risk Management: Identify potential compliance risks and implement corrective and preventive actions.
Stakeholder Engagement: Maintain strong relationships with regulatory authorities, industry bodies, and other stakeholders.
Monitoring and Reporting: Track regulatory changes, ensure timely updates to processes, and prepare compliance reports for senior management.

Education Qualifications: Minimum Requirements: Bachelor’s degree in Pharmacy, Life Sciences, Regulatory Affairs, or related field.
Preferred: Master’s degree in Regulatory Affairs, Pharmaceutical Sciences, or Healthcare Management.
Certifications: Relevant certifications such as RAC (Regulatory Affairs Certification) or similar qualifications are advantageous.
Experience: Extensive experience in regulatory affairs and compliance roles within the pharmaceutical industry, including leadership experience.

Key Attributes: Strategic Vision: Ability to align regulatory and compliance strategies with organizational goals.
Leadership: Proven skills in managing and mentoring regulatory and compliance teams.
Analytical Thinking: Proficiency in interpreting complex regulatory guidelines and identifying risks.
Communication: Strong interpersonal skills for engaging with regulators and internal stakeholders.
Ethical Integrity: Commitment to maintaining high ethical standards and organizational transparency.
Attention to Detail: Precision in regulatory documentation and compliance tracking.

About the Role: The Compliance and Regulatory Head ensures that the organization operates within the framework of legal, ethical, and regulatory standards. This role is critical in securing product approvals, minimizing risks, and fostering trust among stakeholders. The position requires strategic leadership, in-depth regulatory knowledge, and the ability to manage complex compliance landscapes in a dynamic industry.