Regulatory Affairs Specialist – Shape the Future of Healthcare Compliance
Summary:
Clinetra Solutions is seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our growing team in Hyderabad. In this pivotal role, you will be responsible for ensuring our pharmaceutical, medical device, and MedTech products meet the highest global regulatory standards. You will play a key role in preparing and submitting regulatory documents, monitoring regulatory updates, and collaborating with cross-functional teams to drive product approvals and maintain compliance. If you are a passionate regulatory professional with a strong understanding of global regulatory frameworks and a desire to contribute to a dynamic and compliance-focused organization, we encourage you to apply.
About Clinetra Solutions:
Clinetra Solutions is a leading provider of regulatory compliance solutions for the pharmaceutical, medical device, and MedTech industries. We are committed to helping our clients navigate the complex regulatory landscape and bring innovative healthcare products to market. Our team of experienced professionals is dedicated to providing high-quality, efficient, and reliable services to meet the evolving needs of our clients.
Job Description:
We are seeking a Regulatory Affairs Specialist to support our regulatory activities across a range of products and global markets. The ideal candidate will possess a strong understanding of regulatory requirements, excellent communication skills, and the ability to work collaboratively in a fast-paced environment.
Key Responsibilities:
- Regulatory Submissions: Prepare, review, and submit comprehensive regulatory documents for product approvals, variations, and renewals to relevant regulatory authorities globally.
- Regulatory Monitoring: Actively monitor and interpret updates in global and local regulatory guidelines, standards, and requirements, and communicate these changes to the relevant teams.
- Agency Liaison: Serve as the primary point of contact for regulatory agencies and notified bodies, responding to inquiries and facilitating effective communication.
- Cross-Functional Collaboration: Collaborate closely with product development, quality, clinical, and marketing teams to ensure regulatory compliance throughout the product lifecycle.
- Labeling and Promotion Review: Review labeling, packaging, and promotional content to ensure compliance with applicable regulations and guidelines.
- Documentation Management: Maintain accurate and up-to-date regulatory databases, files, and inspection-ready documentation.
- Audit and Inspection Support: Support internal and external audits and inspections, including the implementation of Corrective and Preventive Actions (CAPA) as needed.
- Strategic Input: Contribute to the development of regulatory strategies for new markets, product changes, and risk management activities.
Required Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Engineering, or a related field.
- 2–4 years of relevant Regulatory Affairs experience in the pharmaceutical, medical device, or healthcare product industries.
- Proven experience with regulatory submissions to CDSCO / US FDA / EMA or other relevant regulatory authorities.
- Demonstrated understanding of global regulatory frameworks and compliance standards (e.g., GMP, ISO 13485, MDR).
- Excellent written and verbal communication skills, with the ability to present complex information clearly and concisely.
- Strong documentation skills and attention to detail.
- Ability to manage multiple regulatory projects simultaneously and prioritize tasks effectively.
- Proficiency in using regulatory databases and software systems.
Benefits of Working with Clinetra Solutions:
- Expert Collaboration: Opportunity to work closely with industry-leading experts in the pharmaceutical and MedTech sectors.
- Global Exposure: Gain exposure to diverse global regulatory processes and multi-region submission strategies.
- Career Growth: Benefit from a growth-focused environment with comprehensive training and development opportunities.
- Hands-on Experience: Engage in hands-on involvement in audits, compliance initiatives, and product lifecycle management activities.
- Competitive Compensation: Receive a competitive salary commensurate with your experience and skills.
- Location: Hyderabad based on-site work.
To Apply:
If you are a qualified and passionate Regulatory Affairs professional seeking a challenging and rewarding opportunity, we encourage you to apply.