Sr. Executive Regulatory Affairs

Synnat Pharma

Brief :

We are looking for a highly motivated Sr.

Executive Regulatory

Affairs (API) to drive our global regulatory compliance at Synnat Pharma. If you have 3-4 years of relevant experience in API Regulatory Documentation, including expertise in DMF Preparation, ICH Guidelines, FDA, and EMA Regulations, we invite you to join our growing team. You will be instrumental in managing Regulatory Submissions, ensuring eCTD compliance, and engaging with Health Authority Interactions. This role offers an unparalleled opportunity to advance your career by contributing to our expansion into regulated markets and developing robust Regulatory Compliance strategies. We seek individuals eager to grow their expertise in a energetic pharmaceutical environment. Apply now to shape the future of API regulatory excellence with us!

Job Details:

Job Title:Sr. Executive Regulatory AffairsIndustry:Pharmaceuticals (API and Intermediates)Department:Quality Assurance & Regulatory AffairsLocation:Hyderabad, IndiaExperience Required:3-4 Years of relevant experienceSalary:5-9 LPAEducation Area:B.Sc./M.Sc. in Chemistry or a Pharm /M.PharmMinimum Qualification:Bachelor'sLanguages:English,TeluguTravel Requirement:RegularlyJob Type:Full-timeWorkplace:On-site

Job Descriptors (Key Words) Skills Required:

Regulatory Affairs Specialist,API Regulatory Documentation,DMF Preparation,ICH Guidelines,FDA Regulations,eCTD Submissions,Regulatory Compliance,Cross-functional Collaboration,Analytical Thinking,Effective Communication,Pharmaceutical Regulations,Health Authority Interactions

Roles & Responsibilities:





Stakeholder Engagement & Communication

1. Serve as a primary point of contact for interactions with health authorities and regulatory agencies.
2. Liaise effectively with customers to fulfill their regulatory documentation requirements and address inquiries.
3. Collaborate with Quality Assurance to ensure all API manufacturing processes and documentation meet regulatory standards.
4. Communicate regulatory updates and potential risks to senior management and relevant departments.
5. Foster strong relationships with external regulatory consultants and partners as needed.
6. Represent Synnat Pharma in industry forums and discussions related to API regulatory affairs.

Regulatory Compliance & Strategy
1. Monitor and interpret new and evolving regulatory guidelines, including FDA and EMA regulations, to ensure continuous compliance.
2. Assess the impact of regulatory changes on Synnat Pharma's API products and operations.
3. Develop and implement regulatory strategies for new product registrations and market expansions.
4. Provide expert regulatory guidance to internal teams, including R&D;, Quality Assurance, and Manufacturing.
5.



Conduct regular internal audits and reviews to ensure adherence to regulatory requirements and internal SOPs.
6. Participate in cross-functional teams to address regulatory challenges and streamline processes.

Quality Systems & Data Management
1. Maintain organized and accessible electronic and physical archives of all regulatory documents.
2. Ensure data integrity and accuracy in all regulatory submissions and internal records.
3. Support the implementation and maintenance of electronic document management systems (EDMS) for regulatory affairs.
4. Prepare detailed reports on regulatory submission status, approvals, and compliance metrics.
5. Contribute to the continuous improvement of regulatory affairs processes and procedures.
6. Train junior staff on regulatory documentation practices and compliance requirements.

Regulatory Documentation & Submissions
1. Prepare, compile, and maintain comprehensive regulatory documentation for Active Pharmaceutical Ingredients (APIs) in accordance with ICH Guidelines.
2. Support the preparation and submission of Drug Master Files (DMFs) for various health authorities, including FDA and EMA.
3. Manage and update existing regulatory submissions, ensuring timely amendments and renewals.
4. Coordinate and prepare responses to health authority queries and customer requests related to regulatory filings.
5. Ensure all regulatory documents comply with Common Technical Document (CTD) and electronic Common Technical Document (eCTD) formats.
6. Oversee the lifecycle management of regulatory documents from initial submission through approval and maintenance.

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