Regulatory Affairs Specialist - Hyderabad
8 hours ago
Job description
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 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.
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