Reglysis stands out for its commitment to delivering reliable, innovative, and comprehensive regulatory solutions. They specialize in navigating the complex landscape of the life sciences industry, covering medical devices, pharmacovigilance, and broader regulatory affairs. Their expertise ensures seamless compliance with global regulatory frameworks, making them a trusted partner for companies navigating the complexities of bringing life-saving products to market. Joining Reglysis means becoming part of a team that is dedicated to excellence and committed to shaping the future of the life sciences sector.
The Role: Regulatory Affairs Specialist
Reglysis is currently seeking a talented Regulatory Affairs Specialist to join their team in Hyderabad. This pivotal role is central to driving compliance and developing robust regulatory strategies across diverse markets. The ideal candidate will be responsible for preparing and submitting a wide range of regulatory documents, working collaboratively with cross-functional teams, and staying ahead of the curve in an ever-evolving regulatory environment. This is an excellent opportunity for individuals searching for Regulatory Affairs Specialist Jobs in Hyderabad.
Key Responsibilities:
- Regulatory Submissions: The core of the role involves preparing and submitting critical regulatory documents. This includes (but is not limited to) 510(k) applications, PMA submissions, CE Marking documentation, IND applications, NDA submissions, MAA filings, and other essential regulatory packages. The specialist will need to ensure all submissions are accurate, complete, and adhere strictly to the guidelines and requirements of regulatory bodies.
- Compliance and Guidelines: A deep understanding of regulatory guidelines is paramount. The Regulatory Affairs Specialist will be responsible for ensuring that all activities and submissions comply with stringent regulations such as those set by the FDA (Food and Drug Administration), EMA (European Medicines Agency), MDR (Medical Device Regulation), IVDR (In Vitro Diagnostic Medical Devices Regulation), ISO 13485 (Quality Management Systems), ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), and other relevant standards.
- Documentation and Strategy: This role requires developing comprehensive technical files, conducting thorough risk assessments, and crafting effective regulatory strategies to secure product approvals across various markets. The ability to synthesize complex information into clear, concise, and persuasive documentation is essential.
- Health Authority Interactions: The specialist will interact directly with global health authorities to address queries, provide clarification, and navigate the approval processes. This includes responding to inquiries, providing additional data, and managing communications to facilitate timely approvals.
- Monitoring and Vigilance: Proactive monitoring of adverse events, recalls, and other critical regulatory updates is a key responsibility. The specialist needs to stay informed about any changes in the regulatory landscape that could impact products or strategies. This involves keeping a vigilant eye on post-market surveillance data and other relevant information.
- Cross-Functional Collaboration: The Regulatory Affairs Specialist will work closely with various internal teams, including Research and Development (R&D), Quality Assurance, and Clinical teams, to support their regulatory needs. This requires effective communication, collaboration, and the ability to integrate regulatory requirements into the overall product development lifecycle.
Location: Hyderabad
This exciting opportunity is based in Hyderabad, a thriving hub for the pharmaceutical and life sciences industries. This location provides ample opportunities for professional growth and networking within the sector.
Why Choose this Job?
- Impactful Work: Play a critical role in ensuring patient safety and bringing life-saving products to market.
- Career Growth: The life sciences industry is dynamic, and Reglysis offers the chance to continuously learn and develop your skills.
- Collaborative Environment: Work with a team of experts who are passionate about regulatory affairs and dedicated to excellence.
- Competitive Compensation: Reglysis offers a competitive salary and benefits package.
How to Apply
If you are an enthusiastic professional with a passion for the life sciences industry. Don’t miss this great opportunity.
Submit your resume to: INFO@REGLYSIS.COM
