Regulatory Affairs Expert for ANDA Submissions

1 week ago


Ahmedabad, Gujarat, India SWASTIK PLACEMENT AGENCY Full time

Job Summary

At SWASTIK PLACEMENT AGENCY, we are seeking a highly skilled Regulatory Affairs Officer to facilitate the preparation and submission of ANDA (Abbreviated New Drug Application) documents. As part of our team, you will be responsible for ensuring compliance with regulatory requirements related to drug products.

About You

We are looking for an individual with extensive experience in reviewing stability data, preparing validation reports, and facilitating eCTD software usage for SPL generation and registration submissions. Your expertise in handling complex regulatory requirements and collaborating with cross-functional teams is crucial to our success. If you have hands-on experience with eCTD software (PharmaReddy) and a passion for delivering high-quality results, we encourage you to apply for this exciting opportunity.

Key Responsibilities

- Review and analyze stability data to ensure compliance with ICH Q6-A guidelines
- Collaborate with cross-functional teams to prepare validation reports and human prescription drug labeling
- Facilitate the preparation of sections 1.14 in module 1 of ANDA dossier and other critical sections
- Utilize eCTD software (PharmaReddy) for SPL generation, registration of new drug products, sequence creation, and uploading modules for eCTD submissions
- Ensure timely submission of documents via ESG

Requirements

- Bachelor's degree in a relevant field (e.g., Life Sciences, Chemistry, or Pharmacy)
- At least 3 years of experience in regulatory affairs, preferably in ANDA submissions
- Strong knowledge of ICH Q6-A guidelines and FDA regulations
- Excellent communication and project management skills
- Proficiency in eCTD software (PharmaReddy) and Microsoft Office Suite

What We Offer

- Competitive salary: $85,000 - $110,000 per annum (dependent on experience),
- Opportunities for professional growth and development,
- Collaborative and dynamic work environment,
- Comprehensive benefits package including medical, dental, and vision insurance,
- Generous paid time off and holidays,
- Access to cutting-edge technology and tools,
- Recognition and rewards for outstanding performance,
- And more

How to Apply

If you're a motivated and detail-oriented individual with a passion for regulatory affairs, please submit your application, including your resume and a cover letter, to us.



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