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Regulatory Affairs Officers job at Quality Chemical Industries

About the Organization

Cipla Limited is an Indian multinational pharmaceutical company, headquartered in Mumbai. Cipla primarily develops medicines to treat respiratory disease, cardiovascular disease, arthritis, diabetes, depression, and many other medical conditions.

Job Description

By fulfilling these duties and meeting these requirements, Regulatory Affairs Officers ensure that their companies comply with regulatory standards, facilitating the safe and effective development and marketing of products.


Duties and Responsibilities

Regulatory Compliance:

  • Ensure that the company complies with all relevant regulations, laws, and guidelines from regulatory bodies.

  • Monitor changes in regulatory legislation and advise management on the impact of such changes.

Submission and Documentation:

  • Prepare and submit regulatory documents and applications, such as marketing authorization applications, clinical trial applications, and product registrations.

  • Maintain accurate and complete records of regulatory submissions and correspondence.

Product Development Support:

  • Provide regulatory guidance throughout the product development lifecycle, from initial concept to market launch.

  • Ensure that product development meets regulatory requirements for safety, efficacy, and quality.

Labeling and Packaging:

  • Review and approve product labeling, packaging, and promotional materials to ensure compliance with regulatory standards.

  • Ensure that product information is accurate, comprehensive, and compliant with regulations.

Liaison with Regulatory Authorities:

  • Act as the primary contact between the company and regulatory authorities.

  • Facilitate communication and negotiations with regulatory bodies to ensure timely approval of products.

Internal Coordination and Training:

  • Coordinate with various departments (e.g., R&D, Quality Assurance, Marketing) to ensure regulatory requirements are met.

  • Provide training and support to staff on regulatory policies, procedures, and best practices.

Risk Management:

  • Identify potential regulatory risks and develop strategies to mitigate them.

  • Ensure that risk management plans are in place and adhered to throughout the product lifecycle.

Audit and Inspection Support:

  • Prepare for and support regulatory audits and inspections.

  • Address and resolve any findings or non-compliance issues identified during audits.

Regulatory Strategy Development:

  • Develop and implement regulatory strategies to expedite the approval and market entry of products.

  • Keep abreast of global regulatory trends and incorporate them into the company’s regulatory strategy.

Post-Market Surveillance:

  • Monitor and report adverse events and product complaints to regulatory authorities.

  • Ensure compliance with post-market surveillance requirements and maintain vigilance reporting systems.

Document Control:

  • Maintain up-to-date regulatory documentation and ensure its accessibility for audits and inspections.

  • Implement document control systems to manage regulatory records efficiently.

Ethical and Legal Standards:

  • Ensure that all regulatory activities adhere to ethical standards and legal requirements.

  • Promote a culture of regulatory compliance and integrity within the organization.

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Qualification, Experiences and Competencies

  • Bachelor's Degree in Pharmacy.

  • Registered Pharmacist with 3+ years' experience in Industry.

  • High analytical mind, with exceptional problem-solving skills and attention to detail.

  • Regulatory and compliance management experience in a regulated environment.

  • Self-starter, flexible and with excellent communication skills, both oral and written.

How to Apply

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