Senior Executive Regulatory Affairs Jobs – Amneal Careers, Ahmedabad | Apply Now
Looking for top Regulatory Affairs jobs? Amneal Careers is hiring a Senior Executive, Regulatory Affairs in Ahmedabad specializing in US Injectable-Pre Approval ANDA submissions. This role is ideal for professionals with expertise in sterile dosage forms (Injectables, Ophthalmic, Otic, IV Bags) and FDA regulatory requirements. Join Amneal Careers to drive timely approvals and contribute to innovative pharmaceutical solutions.
Job Details:
- Job Title: Senior Executive, Regulatory Affairs
- Location: Shapath-V, Near Hotel Crown Plaza, Ahmedabad, Gujarat, 380015, India
- Job ID: 6500
- Job Category: Regulatory Affairs
About The Company:
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
Job Description:
The Senior Executive, Regulatory Affairs at Amneal Careers manages and submits ANDA filings for US sterile dosage forms. Ensure compliance with FDA regulations, timely submissions, and proactive issue resolution while collaborating with cross-functional teams.
Key Responsibilities | Regulatory Affairs Jobs at Amneal Careers:
- Compile, prepare, review, and submit ANDA submissions and amendments to the FDA.
- Maintain awareness of regulatory activities on assigned projects.
- Evaluate change controls and regulatory strategies with minimal supervision.
- Prepare controlled correspondence and pre-submission packages (Pre-ANDA, Pre-IND, Pre-NDA).
- Respond to FDA deficiency letters with gap assessment and strategy formulation.
- Collaborate with R&D, Quality, and Purchase teams for timely document availability.
- Systematically archive all submissions.
- Support project management and continuous improvement initiatives.
Skills Required | Regulatory Affairs Jobs :
- Regulatory Submission & Dossier Filing | Advanced
- Regulatory Guidelines Knowledge | Advanced
- Change Control & Regulatory Impact Assessment | Advanced
- Product Lifecycle Management | Advanced
- CMC Documentation | Advanced
- Health Authority Query Response | Advanced
- Regulatory Strategy Development | Advanced
- Cross Functional Communication, Problem Solving & Risk Mitigation | Intermediate
Qualifications Required For Regulatory Affairs Jobs :
- M. Pharm or equivalent degree
- Prior experience with ANDAs, INDs, NDAs, and FDA correspondence
- Expertise in sterile dosage forms (Injectables, Ophthalmic, Otic, IV Bags)
- Knowledge of ICH, FDA, and 21 CFR regulations
- Strong technical writing, time management, and problem-solving skills
