Urgent Hiring Regulatory Affairs job Assistant Manager – USA Market at Adaptis Pharma (Pune)

Updated February 9, 2025
Posted in Degree Jobs / Pharmacy Jobs
0 Comments
2 mins read

Urgent Hiring Regulatory Affairs job Assistant Manager – USA Market at Adaptis Pharma (Pune)

Table of Contents

Regulatory Affairs Jobs in Pune: Assistant Manager Opportunity at Adaptis Pharma

Regulatory Affairs Jobs in Pune: Assistant Manager Opportunity at Adaptis Pharma

Adaptis Pharma, a leading player in the pharmaceutical industry, is currently seeking a highly qualified and experienced Regulatory Affairs Assistant Manager to join our dynamic team in Pune. This is an excellent opportunity for experienced professionals with a strong background in regulatory affairs for the USA market to contribute to the success of innovative pharmaceutical products.

Key Responsibilities

Preparation of ANDA/NDA submissions for Solid Orals and Injectables, with a focus on writing key sections of M1, M2, M3, and M5 modules.
Thorough review of CMC, labeling, and bioequivalence documents for regulatory submissions.
Expertise in eCTD compilation and submission procedures.
Rigorous review of Original ANDA submissions.
Drafting comprehensive responses to queries raised during the ANDA review cycle.
Providing support for post-approval supplements.

Qualifications and Experience

Education: M.Pharm/B.Pharm
Experience: 4-6 years of hands-on experience in regulatory affairs for the USA market.
Strong understanding of US FDA regulations and guidelines.
Proven experience in writing and reviewing regulatory submissions (ANDA/NDA).
Excellent written and verbal communication skills.
Strong analytical and problem-solving abilities.
Proficient in Microsoft Office Suite and regulatory software.

Why Adaptis Pharma?

Opportunity to work on challenging and rewarding projects.
Collaborative and supportive work environment.
Opportunities for professional growth and development.

How to Apply

Interested candidates should send their resumes to: [email protected]

Note:

This is a sample blog post and can be further expanded with additional details about Adaptis Pharma and the company culture.
Ensure the blog post is well-formatted with clear headings, bullet points, and images to improve readability.
Promote the blog post on relevant platforms like LinkedIn and industry-specific job boards.

By implementing these SEO best practices, you can effectively reach a wider audience of qualified candidates and increase the visibility of this job opening.