Key Responsibilities:
Ensure compliance with all applicable regulations and standards for products in the company's portfolio.
Prepare and submit regulatory documents (e.g., dossiers, applications) for product registration and approvals.
Maintain up-to-date knowledge of international and domestic regulatory requirements.
Communicate with regulatory agencies (e.g., FDA, EMA, DCGI) and respond to inquiries.
Develop and implement regulatory strategies for new product launches and existing products.
Monitor post-market surveillance, ensuring timely reporting of adverse events and regulatory updates.
Manage the lifecycle of regulatory submissions, including renewals, variations, and amendments.
Provide regulatory support to cross-functional teams, including R&D, Quality Assurance, and Manufacturing.
Maintain detailed records and documentation related to all regulatory activities.
Train and educate internal teams on regulatory compliance and changes in regulations.
Requirements:
Bachelor's or Master’s degree in Pharmacy, Life Sciences, or a related field.
3-5+ years of experience in regulatory affairs within the pharmaceutical, medical device, or related industry.
Strong understanding of regulatory guidelines (e.g., FDA, EMA, ICH, WHO).
Experience in preparing and submitting regulatory filings and dossiers.
Strong attention to detail and ability to manage multiple projects.
Excellent communication and interpersonal skills.
Ability to stay up-to-date with evolving regulations.
Preferred:
Experience with regulatory submissions in multiple regions.
Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
Approach is a platform where the employer and the employee can connect for one goal, Professional Networking. Our user-friendly experience ensures that individuals from different fields can connect to each other with complete transparency and get the... Read More
