Senior Executive

LYWO RECRUITMENT CONSULTING; Hyderabad; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Synnat Pharma in Hyderabad, India, seeks a Sr. Executive Regulatory Affairs (API) to drive global regulatory compliance.

The role focuses on regulatory submissions, eCTD, and interactions with Health Authorities, leveraging 3-4 years of API regulatory documentation experience. Responsibilities include ensuring CTD/eCTD format compliance, supporting DMF submissions, and shaping regulatory strategies for market expansion.

Qualifications

• 3-4 years of API regulatory documentation experience.
• Expertise in DMF preparation.
• Familiar with ICH guidelines and FDA/EMA regulations.
• Experience with health authority interactions.
• Willing to contribute to regulatory compliance strategy.

Responsibilities

• Serve as primary contact for interactions with health authorities and regulatory agencies.
• Coordinate with customers to fulfill regulatory documentation requirements and inquiries.
• Collaborate with Quality Assurance to ensure API manufacturing documentation meets regulatory standards.
• Communicate regulatory updates and potential risks to senior management and relevant departments.
• Engage with external regulatory consultants and partners as needed.
• Represent Synnat Pharma in industry forums and discussions related to API regulatory affairs.

Skills

Regulatory affairs

DMF preparation

eCTD

FDA regulations

EMA regulations

Job description

Sr. Executive Regulatory Affairs
Synnat Pharma

Brief Job Description:
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 dynamic pharmaceutical environment. Apply now to shape the future of API regulatory excellence with us!

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.