Endo International is a global specialty pharmaceutical company dedicated to delivering life-enhancing solutions through innovation and operational excellence. With a focus on improving patients’ lives, Endo’s portfolio encompasses branded and generic pharmaceuticals, specializing in areas like injectable and oral solid dosage forms (OSD). Endo fosters a diverse, equitable, and inclusive culture that celebrates individual uniqueness and empowers its global workforce to drive collective success.

Job Responsibilities

As a Regulatory Affairs Associate based in Chennai or Indore, you will play a vital role in ensuring compliance with global regulatory standards and supporting the company’s pharmaceutical product portfolio. The responsibilities include:

1. Regulatory Submission:
   • Preparation, review, and submission of amendments and supplements for assigned products, including injectable and OSD dosage forms.
   • Compilation and submission of Global Annual Reports.
   • Creation of summary documents for regulatory submissions.
2. Agency Interactions:
   • Preparation, review, and submission of responses to agency queries.
3. Document Review:
   • Evaluation of stability protocols, reports, and analytical method validation documents.
   • Review of raw materials, packaging materials, finished product specifications, and testing procedures.
   • Examination of batch records and executed BMR (Batch Manufacturing Records).
   • Review of process validation protocols, hold-time studies, and related reports.
   • Analysis of product development reports and certificates of analysis to ensure compliance with regulatory requirements.
4. Cross-functional Collaboration:
   • Coordination with various departments to ensure documents meet regulatory expectations.

Qualifications To excel in this role, candidates should possess the following qualifications:

• Bachelor’s or Master’s degree in Pharmacy, Science, or a related field.
• Proven experience in regulatory affairs, specifically handling injectable and OSD dosage forms.
• Knowledge of global regulatory standards and requirements.

Skills Required

• Strong analytical and problem-solving abilities.
• Proficiency in regulatory documentation and dossier preparation.
• Excellent written and verbal communication skills.
• Attention to detail and commitment to ensuring compliance.
• Ability to manage multiple projects and meet tight deadlines.

Application Link