Discover the Exciting Job of a Regulatory Affairs Manager in a Leading Pharmaceutical Organization!

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"Discover the Exciting Job of a Regulatory Affairs Manager in a Leading Pharmaceutical Organization!"

Job Posting: Regulatory Affairs Manager

About the Company:

Our company is a leading pharmaceutical organization with a strong presence in India. We specialize in consumer healthcare products, pharmaceuticals, and food supplements. As a Regulatory Affairs Manager, you will be responsible for leading regulatory activities in the India/Srilanka/Nepal/Maldives market. Your role will involve developing regulatory strategies and submissions for new products, ensuring compliance with regulations, and optimizing cross-functional support within the organization.

Location: Mumbai

Job Type: Permanent

Job Requisition ID: R2718817

About the Job

Main Responsibilities:

Regulatory Compliance

  • Ensure timely implementation and maintenance of product packaging and associated information in accordance with current product licenses.
  • Update Marketing Authorizations in line with Company Core Safety Information.
  • Ensure compliance and training to all mandatory SOPs.
  • Maintain regulatory quality compliance and update regulatory databases.
  • Stay updated with new regulatory requirements and assess their impact on existing and future products.
  • Review and approve promotional and non-promotional materials for compliance with local regulations.
  • Liaise with local manufacturing facility regarding regulatory activities.

Portfolio Management and Optimization

  • Manage local maintenance activities and ensure compliance of the marketed product portfolio.
  • Prepare local dossiers for products under development and territory extensions.
  • Submit dossiers for local OTC switches.
  • Collaborate with cross-functional teams to optimize the product portfolio.
  • Conduct regulatory due diligence for business collaborations.

Drug & Food Supplements Development and Risk Management

Drug Development:

  • Provide regulatory inputs to global/regional/local teams for new development.
  • Coordinate local health authority approval and implementation of risk management plans.

Regulatory Database:

  • Lead compliance of the regulatory registration database.
  • Ensure regular tracking and closure of submissions.

Qualifications and Experience

  • Degree in Pharmacy or Science or relevant Academic qualification.
  • About 3-5 years of experience in Regulatory Affairs, including India and South Asia market.
  • Good understanding of the consumer healthcare and pharmaceutical industry.
  • Knowledge of local consumer healthcare regulations and requirements.
  • Fluent in spoken and written English.

Link to Original Notification: Sanofi Careers – Regulatory Affairs Manager

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