Title:  Senior Manager Regulatory Surveillance

Job Title: Manager / Senior Manager Regulatory Surveillance

Job Location : Baroda

Job Summary:

The Regulatory Surveillance Manager/Sr. Manager is responsible for monitoring, analysing, and implementing new or modified regulatory guidance documents, ensuring that the organization remains compliant with all applicable regulatory standards.

Key Responsibilities:

• Continuously track new and updated regulatory guidance, standards relevant to the organization’s operations, including those from global regulatory agencies (e.g., USFDA, EMA, WHO, MHRA, HC, CDSCO etc.).

• Analyze and interpret regulatory changes to determine their impact on company operations, products, and services.

• Assess and execute a plan to implement new or modified regulations within the organization, ensuring compliance deadlines are met.

• Circulate regulatory updates across relevant departments, providing clear guidance on necessary adjustments to policies, procedures, or product documentation.

• Work closely with departments such as Quality Assurance, Regulatory Affairs, Operations and R&D to ensure that all aspects of compliance are integrated into daily operations.

• Assist in assessing compliance risks associated with new regulations and propose mitigations where necessary.

• Maintain detailed records of regulatory updates, impact assessments, and implementation efforts. Generate reports to communicate the status of compliance efforts to senior management and regulatory authorities as required.

• Assist in preparing for regulatory audits and inspections by ensuring all relevant documentation and processes are compliant with the latest regulations.

Qualifications:

• Master/Bachelor’s degree in Regulatory Affairs, Quality Assurance, Life Sciences, Pharmaceutical Sciences, or a related field.

• Minimum 10-15 years of experience in regulatory surveillance, compliance, or a related field.

• Good understanding of global regulatory frameworks (FDA, EMA, WHO, ICH, etc.).

• Excellent communication skills for cross-functional collaboration.

• Experience in preparing for regulatory audits and inspections.

• Proficient in regulatory monitoring tools and databases.

Preferred Skills:

• Experience in pharmaceuticals, medical devices, or biotechnology industries.

• Project management skills to handle multiple regulatory initiatives simultaneously.