Job Description

We are looking for a detail-oriented and experienced Regulatory Affairs Manager to join our pharmaceutical team. In this role, you will be responsible for ensuring that all pharmaceutical products comply with local and international regulatory requirements. You will oversee the preparation and submission of regulatory documents, as well as collaborate with cross-functional teams to ensure that new products are brought to market in a compliant and timely manner.

Job Responsibilities

• Lead the preparation, review, and submission of regulatory filings (e.g., INDs, NDAs, ANDAs) to health authorities (FDA, EMA, etc.).
• Develop regulatory strategies for product development, approvals, and post-marketing activities.
• Monitor and interpret global regulatory requirements to ensure compliance throughout the product lifecycle.
• Work closely with research, development, and marketing teams to ensure alignment with regulatory guidelines.
• Act as the primary point of contact with regulatory authorities during the approval process.