Regulatory Specialist

Job Title: Regulatory Affairs Specialist

Job Summary: The Regulatory Affairs Specialist/Manager is responsible for ensuring that the company’s products meet all regulatory requirements and standards. This role involves managing the regulatory submission process, collaborating with cross-functional teams, and ensuring compliance with local, regional, and international regulations throughout the product lifecycle.

Key Responsibilities:

• Regulatory Submissions:
• Prepare and submit regulatory documents for product approvals, including applications, dossiers, and amendments.
• Ensure that all submissions meet the regulatory requirements of relevant authorities (e.g., FDA, EMA, etc.).
• Regulatory Strategy:
• Develop and implement regulatory strategies for product development and marketing.
• Provide regulatory advice to product development teams and senior management to ensure compliance and minimize risks.
• Compliance Monitoring:
• Monitor and interpret regulatory changes and industry trends, ensuring the company’s products remain compliant.
• Conduct periodic audits and reviews of regulatory practices within the company.
• Cross-functional Collaboration:
• Work closely with R&D, manufacturing, quality assurance, and marketing teams to ensure all regulatory aspects are considered in product design and commercialization.
• Liaise with external regulatory bodies as necessary to facilitate approvals.
• Regulatory Documentation:
• Maintain up-to-date knowledge of all regulatory documents, including product specifications, labeling, and promotional materials.
• Ensure timely reporting of adverse events and product recalls as required by authorities.
• Training and Guidance:
• Provide regulatory training and guidance to other departments within the company.
• Advise teams on the regulatory implications of business decisions.

Qualifications:

• Bachelor’s degree in Life Sciences, Chemistry, Pharmacology, or a related field (advanced degrees preferred).
• 2+ years of experience in regulatory affairs, preferably in the relevant industry (pharmaceuticals, medical devices, etc.).
• Familiarity with international regulatory guidelines and standards (FDA, EMA, ICH, etc.).
• Strong written and verbal communication skills.
• Detail-oriented with strong organizational skills.
• Ability to work independently and manage multiple projects simultaneously.

Preferred Skills:

• Experience with regulatory submissions such as IND, NDA, 510(k), CE Marking, etc.
• Knowledge of global regulations and market approval processes.
• Certification from regulatory bodies (e.g., RAC) is a plus.

Job Type: Full-time

Pay: ₹20,000.00 - ₹30,000.00 per month

Schedule:

• Day shift

Work Location: In person