Senior Regulatory Affairs Executive

We are looking for a meticulous Senior Executive or Assistant Manager to lead regulatory filings at Synnat Pharma Pvt Ltd, a rapidly expanding company in the Active Pharmaceutical Ingredient (API) industry. In this pivotal role, you will be instrumental in navigating the complex landscape of pharmaceutical regulations, ensuring our API products meet the stringent requirements of global regulatory bodies, particularly the US FDA. Your expertise will be crucial in preparing and submitting Drug Master Files (DMFs) and eCTD-compliant documentation, managing regulatory inspections, and proactively mitigating regulatory risks. You will collaborate closely with API manufacturing, quality control, and research teams to develop and implement robust regulatory strategies. Responsibilities will also include conducting regulatory audits, ensuring adherence to ICH guidelines, and managing the lifecycle of API products from a regulatory perspective. A deep understanding of pharmaceutical regulations, coupled with the ability to interact with regulatory authorities, will be essential for ensuring compliance and expanding into regulated markets.

Job Details:

• Industry:

  Active Pharmaceutical Ingredients (API)

• Department:

  Regulatory Affairs

• Role:

  Senior Executive / Assistant Manager Regulatory Affairs

• Location:

  Visakhapatnam

• Compensation:

  5 to 10 LPA

• Experience:

  7 to12 years

• Employment Type:

  Full-time

• Qualification:

  Bachelors or Master’s degree in Pharmacy, Chemistry, or a related field

Responsibilities:

• Prepare, review, and submit comprehensive regulatory filings including DMFs, variations, and renewals, ensuring compliance with global regulations.
• Manage the

  eCTD compilation and submission

  process for API products, ensuring accuracy and adherence to timelines.
• Lead documentation preparation for regulatory inspections, responding to queries from authorities.
• Conduct

  regulatory audits

  of API manufacturing processes to ensure compliance with

  cGMP

  requirements.
• Develop and implement

  CAPA plans

  to address regulatory gaps or deficiencies.
• Monitor and track the status of filings, proactively addressing issues to secure timely approvals.
• Develop regulatory strategies for API products, considering market access requirements and regulatory trends.
• Identify and mitigate regulatory risks, ensuring compliance with

  ICH and US FDA

  guidelines.
• Provide regulatory guidance and support to cross-functional teams and ensure change control compliance.
• Manage the

  regulatory aspects of API product lifecycle

  from development through commercialization and post-market surveillance.
• Collaborate with manufacturing, QC, and R&D teams to ensure compliance throughout the product lifecycle.
• Participate in product recalls, adverse event reporting, and lifecycle management activities.
  

General Expectations and Experience:

• 7–12 years of proven experience in API Regulatory Affairs
• Strong knowledge of US FDA regulations, ICH guidelines, and cGMP compliance.
• Hands-on expertise in DMF preparation, eCTD submissions, and regulatory audits/inspections.
• Experience in API manufacturing processes and documentation requirements.
• Excellent communication, documentation, and negotiation skills with regulatory authorities.
• Proficiency in Regulatory Compliance Management and change control processes.