Assistant Manager Quality Assurance & Regulatory Affairs

Synnat Pharma

Brief :

We seek a highly experienced Assistant Manager, Quality Assurance & Regulatory Affairs (QA & RA) to spearhead API Regulatory Documentation and GMP Compliance at Synnat Pharma. If you possess 8-11 years of expertise in Regulatory Affairs Management, including lifecycle management for APIs, Drug Master File (DMF) submissions, and navigating ICH Guidelines, this role is for you. You will be instrumental in ensuring our Active Pharmaceutical Ingredients (API) meet global Pharmaceutical Regulations, managing Regulatory Submissions, and engaging in critical Regulatory Authority Interactions.

This is an exceptional opportunity to contribute to our expansion into regulated markets, developing your strategic regulatory planning and change control assessment skills within a dynamic public company. Join us to elevate your career and shape our global quality and regulatory landscape. Apply now to be part of our success story!

Job Details:

Job Title: Assistant Manager -Quality Assurance & Regulatory Affairs

Industry: Pharmaceuticals (API and Intermediates)

Department:Quality Assurance & Regulatory Affairs

Location: Hyderabad, India

Experience Required:8 to 11 years of relevant experience

Salary:7 to 12 LPA

Education Area: B.Sc./M.Sc. in Chemistry or a Pharm / M.Pharm

Minimum Qualification: Bachelor's

Languages: English, Telugu

Travel Requirement :Regularly

Job Type :Full-time

Workplace :On-site

Job Descriptors (Key Words) Skills Required:

Regulatory Affairs Management,Quality Assurance,API Regulatory Documentation,GMP Compliance,ICH Guidelines,Regulatory Submissions,Lifecycle Management (APIs),



Change Control Assessment,Pharmaceutical Regulations,Leadership,Analytical Thinking,Effective Communication

Roles & Responsibilities:

Regulatory Authority & Customer Interactions

1. Serve as a primary contact for regulatory authorities regarding API submissions and compliance matters.
2. Coordinate and facilitate communication with customers concerning regulatory documentation and quality inquiries.
3. Address and resolve regulatory queries and issues efficiently to minimize impact on product timelines.
4. Build and maintain strong professional relationships with regulatory bodies and key stakeholders.

Strategic Regulatory Planning

1. Contribute to the development and implementation of regulatory strategies for new API products and market expansions.
2. Monitor the regulatory landscape for emerging trends, new regulations, and guidance documents impacting API manufacturing.
3. Provide strategic input on regulatory pathways and requirements for different semi-regulated, non-regulated, and regulated markets.
4. Support the company's foray into regulated markets by ensuring all regulatory preparations are robust and compliant.

Change Control & Impact Assessment

1. Assess the regulatory impact of product, process, analytical, and vendor-related changes.
2. Manage the change control process from a regulatory perspective, ensuring all necessary documentation and approvals are in place.
3.



Collaborate with R&D;, Production, and Quality Control teams to evaluate the regulatory implications of proposed changes.
4. Ensure that all changes are documented and implemented in accordance with regulatory commitments and approved company procedures.

Regulatory Documentation & Submissions

1. Manage and coordinate the preparation, review, and submission of regulatory documentation for new and existing Active Pharmaceutical Ingredients (APIs).
2. Ensure timely and accurate compilation of Drug Master Files (DMFs) and other regulatory dossiers according to ICH guidelines and specific market requirements.
3. Oversee the lifecycle management activities for API regulatory submissions, including amendments, variations, and renewals.
4. Prepare and submit responses to inquiries from regulatory authorities and customers in a timely and compliant manner.
5. Maintain up-to-date knowledge of global pharmaceutical regulations and guidelines relevant to API manufacturing and quality.

Quality Assurance & GMP Compliance

1. Ensure strict compliance with applicable Positive Manufacturing Practices (GMP) requirements across all relevant operations.
2. Implement and monitor quality assurance processes to maintain high standards for API production and documentation.
3. Participate in internal and external audits, including regulatory inspections, and ensure timely closure of any identified observations.
4. Develop and revise Standard Operating Procedures (SOPs) related to Quality Assurance and Regulatory Affairs activities.
5. Provide guidance and training to staff on GMP principles, regulatory requirements, and quality system procedures.

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