Intas Pharma Hiring for Regulatory Affairs
Key Points
| Position Name | Senior Executive / Assistant Manager / Manager |
|---|---|
| Organization | Intas Pharma |
| Qualifications | M.Pharm / MSc / Biotechnology / Biological Sciences / Pharmacy |
| Experience | 6-8 years |
| Salary | ₹5.1 L/yr – ₹8.3 L/yr |
| Location | Ahmedabad, Biopharma Plant |
| Walk-in Interview Date | 20th October 2024 |
| Interview Time | 09:00 AM to 06:00 PM |
| Application Deadline | 20th October 2024 |
| Interview Format | Virtual via MS Teams |
Join Intas Pharma: Elevate Your Career in Regulatory Affairs
Intas Pharma, a leading player in the biopharmaceutical sector, is on an exciting growth trajectory and is expanding its Regulatory Affairs team. This is a unique opportunity for ambitious professionals with a solid background in regulatory affairs to contribute to the company’s mission of delivering high-quality biopharmaceutical products. Intas Pharma Hiring for Regulatory Affairs
About Intas Pharma
Intas Pharma is a renowned pharmaceutical company that has established itself as a global player in the healthcare sector. With a strong focus on innovation and quality, Intas Pharma develops a wide range of pharmaceutical products, including biosimilars and biologics, aimed at addressing the healthcare needs of patients worldwide. The company’s commitment to research and development, along with its robust manufacturing capabilities, makes it a sought-after employer in the industry. Intas Pharma Hiring for Regulatory Affairs
Position Overview
Intas Pharma is looking for qualified candidates for the positions of Senior Executive, Assistant Manager, and Manager in Regulatory Affairs. The selected candidates will be pivotal in ensuring that the company’s products meet the regulatory requirements of various global markets. Intas Pharma Hiring for Regulatory Affairs
Purpose of the Job
In these roles, you will be responsible for preparing and submitting regulatory filings necessary for obtaining licenses and approvals in regulated markets. Your work will involve close collaboration with cross-functional teams to ensure that all regulatory requirements are met effectively and efficiently. Intas Pharma Hiring for Regulatory Affairs
Key Responsibilities
As a member of the Regulatory Affairs team, your key responsibilities will include:
- Preparation and Submission of Regulatory Filings: You will prepare, review, and submit Common Technical Document (CTD) sections in compliance with the European Medicines Agency (EMA), the U.S. Food and Drug Administration (USFDA), and other global regulatory bodies.
- Timely Dossier Updates: You will be responsible for the timely update and preparation of dossiers and related documents, including responses to queries from regulatory agencies.
- Registration Applications: Handling the preparation of registration applications, including necessary administrative documents and providing support for GMP (Good Manufacturing Practice) audits.
- Lifecycle Submissions Management: You will manage lifecycle submissions, ensuring all necessary updates and changes are effectively communicated to regulatory authorities.
- Conducting Gap Analysis: Conduct gap analyses for registrations in both regulated and semi-regulated markets to identify areas for improvement and ensure compliance.
- Change Control Management: Establishing and tracking effective change control management processes for regulatory review and approval.
- Regulatory Information Management System: Participating in the assessment and implementation of the Regulatory Information Management System, contributing to enhanced efficiency in regulatory processes.
- CMC Document Review: Reviewing Chemistry, Manufacturing, and Controls (CMC) documents for compliance and adequacy for filings in regulated markets.
- Assessment of Variations: Assessing change controls and related variation submissions for global markets to ensure ongoing compliance. Intas Pharma Hiring for Regulatory Affairs
Candidate Profile
Intas Pharma is seeking candidates who possess the following qualifications and experience:
- Educational Background: Candidates should hold an M.Pharm, MSc in Biotechnology, Biological Sciences, Pharmacy, or Regulatory Affairs.
- Experience Requirement: A minimum of 6-8 years of relevant experience in CMC writing, electronic Common Technical Document (eCTD) publishing, and regulatory operations, specifically for biosimilars and biologics.
- RAC Certification: While not mandatory, having Regulatory Affairs Certification (RAC) will be considered an added advantage.
- Relocation: Candidates must be willing to relocate to Ahmedabad, as work-from-home options are not available for these positions. Intas Pharma Hiring for Regulatory Affairs
How to Apply
Interested candidates are encouraged to apply for the positions by clicking the link provided in the job announcement. Ensure your application showcases your qualifications and experience in the regulatory affairs domain.
Walk-in Interview Details
Intas Pharma invites you to participate in a walk-in interview for the Regulatory Affairs positions. Here are the details:
- Date: 20th October 2024
- Time: 09:00 AM to 06:00 PM
- Format: The interview will be conducted virtually via MS Teams.
Why Work at Intas Pharma?
Joining Intas Pharma means becoming part of a dynamic team dedicated to making a significant impact in the biopharmaceutical industry. The company values innovation, quality, and integrity, providing its employees with a collaborative and supportive environment. Here are a few reasons to consider a career with Intas Pharma: Intas Pharma Hiring for Regulatory Affairs
- Growth Opportunities: Intas Pharma is committed to the professional development of its employees. The company offers various training programs and career advancement opportunities, enabling you to grow your skills and career.
- Innovative Work Environment: As part of a leading biopharmaceutical company, you will work on innovative projects that contribute to the development of groundbreaking healthcare solutions.
- Impactful Work: Your role in regulatory affairs will be crucial in ensuring that high-quality biopharmaceutical products reach patients in need, making a tangible difference in their lives.
- Supportive Culture: Intas Pharma fosters a culture of teamwork, collaboration, and respect, where every employee’s contributions are valued. Intas Pharma Hiring for Regulatory Affairs
Conclusion
If you are a qualified professional in regulatory affairs with a passion for biopharmaceuticals, don’t miss this opportunity to join Intas Pharma. The company is looking for talented individuals ready to take their careers to the next level. Participate in the walk-in interview on 20th October 2024, and take the first step toward a rewarding career in the dynamic field of regulatory affairs. Your future at Intas Pharma awaits! Intas Pharma Hiring for Regulatory Affairs