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Job as Regulatory Associate/Asst.Manager/Manager in Makro Care - 5 openings

 

Clinical courses

MakroTech is a leading global consulting and technology services company, offering a wide array of solutions customized for a range of key verticals and horizontals. From strategy consulting right through to implementing IT solutions for customers, Makro straddles the entire IT space. It has excellent domain competencies in verticals such as Healthcare, Pharmaceutical, Financial, Telecom, IT, Government and other industries. As a diverse end-to-end IT solutions provider, Makro offers a range of expertise aimed at helping customers re-engineer and re-invent their businesses to compete successfully in an ever-changing marketplace.

Post: Regulatory Associate/Asst.Manager/Manager

Job Description:
Prepare, review and manage timely preparation of Chemistry, Manufacturing and Controls (CMC) sections of global regulatory submissions (CTD format) in support of clinical trial applications and product maintenance according to Regulatory guidelines

Job Profile:
• Prepare CMC responses to various regulatory queries
• Author CMC sections (QOS and Module 3) for submissions such as clinical trial applications and amendments, registration dossiers, annual reports and post approval variations and renewals.


Additional Information:
Experience: 2-7 years
Location:
Hyderabad
Education: B.Pharm, M.Pharm, B.Sc, M.Sc, MBBS
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA

To apply for the job, E-mail your resume to: careers@makrocare.com


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