Manager, Regulatory Affairs

Synnat Pharma

Brief :

We are seeking a dynamic and experienced Manager, Regulatory Affairs to spearhead global API Regulatory Strategy and submissions at Synnat Pharma, a quick-growing leader in API and Intermediates. In this pivotal role, you will lead the development and execution of global regulatory strategies, overseeing Drug Master Files (DMF) and Common Technical Document (CTD) preparation, and managing Health Authority Interactions to ensure successful entry into regulated and semi-regulated markets. Leveraging your 10-12 years of expertise in global regulatory submissions and ICH Guidelines, you will mentor a high-performing team and drive product lifecycle management.

This opportunity offers significant career development in a company expanding into new global markets, allowing you to shape our regulatory future. If you possess a B.Sc./M.Sc. in Chemistry or B.Pharm/M.Pharm and are ready to make a significant impact, we invite you to apply and grow with us!

Job Details:

Job Title:Manager, Regulatory Affairs

Industry:Pharmaceuticals (API and Intermediates)

Department:Regulatory Affairs

Location:Hyderabad

Experience Required:10-12 years

Salary:10-15 LPA

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

Minimum Qualification:Master's

Languages:Telugu,Hindi,English

Travel Requirement:Regularly

Job Type:Full-time

Workplace:On-site

Job Descriptors (Key Words) Skills Required:

Regulatory Affairs Management,API Regulatory Strategy,Global Regulatory Submissions,Drug Master Files (DMF),Common Technical Document (CTD),ICH Guidelines,Regulatory Dossier Preparation,Health Authority Interactions,Team Leadership,Pharmaceutical Regulations,Compliance Management,Regulated Markets Entry

Roles & Responsibilities:

Regulatory Strategy & Leadership

1.



Lead the development and execution of global API Regulatory Strategy in alignment with business objectives and market expansion plans.
2. Provide expert guidance and strategic oversight on all regulatory matters, ensuring compliance with USFDA Regulations, ICH Guidelines, and other relevant health authority requirements.
3. Mentor and develop a high-performing Regulatory Affairs team, fostering a culture of excellence, collaboration, and continuous improvement.
4. Stay abreast of evolving global regulatory landscapes, assessing their impact on Synnat Pharma's product portfolio and regulatory submissions.
5. Drive the successful entry into new regulated and semi-regulated markets by formulating robust regulatory pathways.

Dossier Management & Submissions
1. Oversee the end-to-end preparation, compilation, and submission of high-quality Drug Master Files (DMFs) and Common Technical Documents (CTDs) for APIs.
2. Ensure all regulatory dossiers are accurate, complete, and submitted within established timelines to various health authorities.
3. Manage the lifecycle of regulatory submissions, including amendments, renewals, and annual reports, to maintain product compliance.
4. Implement and maintain robust documentation systems for all regulatory activities and submissions.
5. Coordinate with cross-functional teams (R&D;, QA, QC, Manufacturing) to gather necessary data and documentation for regulatory filings.

Health Authority Interactions & Compliance
1. Serve as the primary point of contact for Health Authority Interactions, responding to queries and managing communication effectively.
2.



Represent Synnat Pharma during regulatory inspections and audits, ensuring all regulatory documentation is readily available and compliant.
3. Proactively identify potential regulatory risks and develop mitigation strategies to ensure uninterrupted market access.
4. Ensure strict adherence to all applicable regulatory guidelines, standards, and internal quality management systems.
5. Facilitate the resolution of any regulatory deficiencies or observations received from health authorities.

Product Lifecycle Management
1. Provide regulatory support throughout the entire Product Lifecycle Management, from development to post-marketing activities.
2. Assess the regulatory impact of proposed changes to API manufacturing processes, raw materials, and specifications.
3. Collaborate with R&D; on current product development projects to integrate regulatory requirements early in the development cycle.
4. Ensure timely updates to regulatory documents in response to product changes or new scientific information.
5. Contribute to the strategic planning for product portfolio expansion and diversification from a regulatory perspective.

Internal Collaboration & Reporting
1. Collaborate effectively with internal stakeholders across departments including R&D;, Quality Assurance, Quality Control, Manufacturing, and Business Development.
2. Provide regular updates and reports on regulatory project status, challenges, and achievements to senior management.
3. Develop and deliver regulatory training to internal teams to enhance overall compliance awareness.
4. Participate in cross-functional project teams to ensure regulatory considerations are integrated into all business decisions.
5. Contribute to the development and refinement of internal Standard Operating Procedures (SOPs) related to regulatory affairs.

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