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Regulatory Compliance Specialist

2 weeks ago

Baddi, Himachal Pradesh, India Acme Generics Full time
Job Description:

The Regulatory Affairs Manager plays a crucial role in ensuring compliance with country-specific regulatory requirements for Acme Generics. As a key member of the team, you will be responsible for compiling dossiers for ROW markets, adhering to module-specific requirements (Module 1-5). This includes ensuring that all submissions align with current regulatory expectations and addressing deficiencies received from agencies in a timely manner.

Key Responsibilities:
  1. Compile dossiers for ROW markets, adhering to country-specific requirements;
  2. Evaluate drug-device combination regulations and ensure submissions comply with country-specific requirements (prefilled syringes and disposable pens);
  3. Maintain consistency and adequacy of submissions through thorough review and revision;
  4. Communicate effectively with stakeholders within the organization and third-party contract manufacturers to resolve delays in submissions;
  5. Lifecycle management of products, including renewals, change control approval, and ensuring product continuity through timely filing and approvals of variations.

Qualifications and Requirements:
  • Proven experience in handling drug-device combination regulations;
  • Strong understanding of regulatory requirements for submission in line with country-specific regulations;
  • Excellent communication and project management skills;
  • Ability to work effectively in a team environment;
  • High level of accuracy and attention to detail.

About Us:
Aacme Generics is a leading pharmaceutical company committed to delivering high-quality products to patients worldwide. We offer a dynamic and collaborative work environment that fosters growth and development.