Company Overview

Gamut HR Solutions is dedicated to helping individuals find the right job opportunities effectively and efficiently. With a small yet dynamic team located in Hyderabad, we strive to connect talented professionals with companies in need of their expertise. Visit our website at http://gamuthrsolutions.com/ to learn more about how we can assist in your career advancement.

Job Overview

We are seeking a dedicated Regulatory Affairs Specialist - Pharma to join our team in Hyderabad. This is a full-time, junior-level position designed for candidates with 1 to 3 years of experience. The chosen candidate will be responsible for a variety of regulatory procedures, ensuring compliance and managing strategic regulatory projects within the pharmaceutical sector.

Qualifications and Skills

• Proficient in FDA regulatory submissions, crucial for the timely approval of products (Mandatory skill).
• Skilled in risk management processes, necessary to identify, assess, and prioritize regulatory risks (Mandatory skill).
• Adept at regulatory strategy development to efficiently navigate and comply with complex regulations (Mandatory skill).
• Solid understanding of EU MDR compliance to ensure product safety and efficacy.
• Experience with quality management systems, enabling efficient organization and processes for regulatory compliance.
• Knowledge of ISO 13485 standards for designing and manufacturing medical devices.
• Competency in labeling and documentation review to ensure accuracy and regulatory compliance.
• Experience in product lifecycle management to oversee the entire regulatory process from development to post-market.

Roles and Responsibilities

• Preparing and submitting regulatory documents to ensure compliance with regional and international regulatory requirements.
• Collaborating with cross-functional teams to support regulatory strategies and submissions.
• Conducting risk assessments and implementing risk mitigation strategies.
• Maintaining up-to-date knowledge of regulatory legislation, guidelines, and standards.
• Reviewing and approving labeling, promotional, and support materials.
• Managing timelines and delivering high-quality regulatory submissions within set deadlines.
• Providing regulatory input for new product development and design changes.
• Participating in regulatory inspections and audits as required.