Regulatory Affairs_ Associate _ API
Full Time
Gurgaon
Posted 1 day ago
Profile: Associate – Regulatory Affairs – API
Location: Gurgaon, Haryana, India (Onsite)
Role Overview:
This role is a mid-level Regulatory Affairs (CMC) position focused on Module 3 (API) documentation for global markets including EU, UK, and US. The primary responsibility is to ensure that all Chemistry, Manufacturing, and Controls (CMC) data submitted to regulatory authorities is accurate, compliant, and aligned with global guidelines.
Job Descriptions:
- CMC review of technical documentation for regulatory filings to various markets – market: EU & UK, US- Gap Analysis and Remediation for module 3 -API
- Prepare and compile Section 322, QOS & QbR ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
- Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
- Demonstrate subject matter and area expertise.
- Collaborate with internal and external clients.
- Supporting and enabling effective and efficient communication that results in operational excellence.
- Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.
Education & Experience:
- Master’s degree or bachelor’s degree in Pharma – MSc Chemistry.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 to 6 years’) or equivalent combination of education, training, & experience.
Knowledge, Skills and Abilities:
- Excellent written and verbal communication skills with a strong attention to detail.
- Proficiency in regulatory submission software and MS Office applications.
- Good problem-solving and coordination skills
- Ability to work in a fast-paced, deadline-driven environment
Behavioural Competencies:
- Detail-oriented with high focus on quality and compliance
- Strong team player with collaborative mindset
- Ability to handle pressure and manage multiple submissions simultaneously.
Why to Join us:
- Growth Opportunities
- Learning Exposure
- Better Compensation