Join JAMP PHARMA: Regulatory Affairs Assistant Manager / Deputy Manager Roles in Ahmedabad

Introduction: Embark on a rewarding career journey with JAMP PHARMA GROUP as we seek talented individuals to join our Regulatory Affairs team. Are you passionate about pharmaceutical regulations and compliance? Do you have the expertise to lead and manage regulatory affairs operations? If yes, then we have exciting opportunities awaiting you. Join us in our mission to deliver high-quality pharmaceutical products to the Australian market. About JAMP PHARMA GROUP: JAMP PHARMA GROUP is a leading pharmaceutical company dedicated to delivering quality healthcare solutions globally. With a commitment to innovation and excellence, we strive to enhance the well-being of individuals by providing access to affordable and high-quality medications. Our company culture emphasizes collaboration, integrity, and continuous learning, making us a preferred employer in the industry. Company Vacancies List: Explore the available positions:

Department: Regulatory Affairs
Position: Assistant Manager / Deputy Manager
Qualification: B Pharma / M Pharma
Experience: 6-12 years
Location: Ahmedabad

Job Description: Role: Assistant Manager / Deputy Manager (Regulatory Affairs) Department: Regulatory Affairs Industry Type: Pharmaceutical Employment Type: Full-time Educational Background Required: B Pharma / M Pharma Experience: 6-12 years Responsibilities:

Review quality Dossiers in CTD format for new Generic drug submissions, in-line with the guidance and templates.
Compile responses to deficiencies letters for the given portfolio of products.
Compile and review the Quality Overall Summary, Module 1 and Module 3 of all planned submissions.
Work closely with cross-functional teams within the organization and third-party teams and maintain good collaboration with all stakeholders CFT for the ongoing projects.
Manage a team of Associates on the day-to-day functioning of the assigned roles.
Provide leadership and mentoring to the Team Leads and Associates.
Prepare and submit due diligence reports of proposed dossiers to Senior Management in India and Canada.
Hands-on experience in MS office (Word, Excel, PowerPoint).

Domain Knowledge: Candidates having exposure in Dossier compilation and review for the Australia market are mandatory, and experience of US/Europe/Canada market will be an added advantage.