Job Title Sr Executive - Regulatory Affairs Country INDIA Region Select State City Industry Cosmetics Salary 3 - 6 (Annual) Department Supply Chain Management No. Of Position 1 Job Type Permanent Work Experience 1 - 4 (Yrs) Education Required Bachelor's Degree Description Regulatory Compliance Management:

- Ensure Compliance: Manage and ensure compliance with all applicable drug control regulations, guidelines, and standards set by government agencies and regulatory bodies.
- Regulatory Requirements: Stay up-to-date with changes in regulatory requirements and ensure that the organization adapts to these changes on time.

Drug Listings and Registrations:
- Product Registrations: Manage the preparation, submission, and tracking of product registration dossiers for recent and existing drugs.
- Listing Approvals: Oversee the process for drug listings with regulatory authorities, ensuring timely approvals and compliance with regulatory standards.

Regulatory Submissions and Documentation:
- Submission Preparation: Prepare and review regulatory submission documents, including New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and other necessary filings.
- Documentation Accuracy: Ensure accuracy and completeness of regulatory documentation to avoid delays or rejections.

Liaison with Regulatory Authorities:
- Agency Interactions: Act as the primary point of contact with regulatory agencies, addressing queries, providing requested information, and negotiating approvals.
- Compliance Discussions: Facilitate discussions and maintain positive relationships with regulatory authorities to support ongoing and future compliance efforts.

Regulatory Strategy Development:
- Strategic Planning: Develop and implement regulatory strategies that align with organizational goals and facilitate efficient product development and market entry.
- Risk Management: Identify and mitigate regulatory risks by developing strategies to address potential compliance issues.





Internal Collaboration and Training:
- Cross-Functional Collaboration: Work closely with internal teams such as R&D;, Quality Assurance, and Legal to ensure regulatory requirements are integrated into product development and operational processes.
- Training Programs: Develop and deliver training programs on regulatory requirements and compliance practices to internal staff.

Audit and Inspection Management:
- Audit Preparation: Prepare for and manage regulatory audits and inspections, ensuring that all necessary documentation and processes are compliant.
- Inspection Follow-Up: Address findings from audits and inspections, implementing corrective actions as required.

Regulatory Intelligence and Reporting:
- Market Intelligence: Monitor and analyze regulatory trends, changes in legislation, and industry best practices to provide insights and recommendations.
- Reporting: Prepare regular reports on regulatory compliance status, upcoming regulatory milestones, and any issues requiring attention.

Product Lifecycle Management:
- Post-Market Surveillance: Oversee regulatory aspects related to the post-market lifecycle of drugs, including monitoring adverse events and ensuring compliance with post-market requirements.
- Labelling and Advertising: Ensure drug labeling and advertising materials comply with regulatory standards and guidelines.

Crisis Management:
- Issue Resolution: Manage regulatory crises or issues, including non-compliance notices or product recalls, to minimize the impact on the organization and ensure prompt resolution.

Requirements

Experience

- Minimum of 4 years of experience in regulatory affairs, preferably within the [industry-specific, e.g., pharmaceutical, medical devices, cosmetics] industry.
- Experience with regulatory submissions in major markets (e.g., FDA, EMA, TGA, etc.).

Benefits

We offer

- Competitive salaries
- Employee recognition program
- Comprehensive insurance plan
- Training & skills upgrading
- Social events

Skill Set No Record Found

📌 Sr Executive - Regulatory Affairs (Secunderabad)
🏢 MAISON D'​ AURAINE
📍 Secunderabad