Regulatory Affairs CMC ANDA submissions Executive or Sr Executive Opportune Solutions

4.0 - 8.0 years

7 - 8 Lacs

nelamangala

Work from Office

Handled ANDA submissions with thorough knowledge on review of CMC documents of dosage: Injectables (simple and complex), Ophthalmics, Topicals, Nasal Sprays and Tablets. knowledge on Module 5 requirements with review & upload study reports. Required Candidate profile Experience of eCTD tools - Educe/Lorenz and/or Pharma Ready. evaluate and respond Agency’s Deficiencies. review DMF. USFDA. Experience of handling submissions related to site transfer products

Posted 2 weeks ago

AI Match Score

Apply

Regulatory Writer Primus Global Technologies

3.0 - 8.0 years

10 - 16 Lacs

hyderabad, chennai, bengaluru

Hybrid

Please find the JD attached below for your reference.Position Scientific Writer / Regulatory WritingExperience- 3-5 Years Sr. Associate/ 7-9 Years – Lead / 10+ years- Associate ManagerLocation- Bang, Hyd, Mumbai, Pune, Delhi NCR (Hybrid-2 day WFO) Full time position Job Description – Regulatory Writing / Medical Writer : The Scientific and Medical content teams at work on different projects across the product life-cycle from regulatory, safety, medical affairs and commercial solutions for our clients. The team leverages the clinical and scientific knowledge and applies to various business problems to reach to various target audiences like the physicians, patients across different therapy are...

Posted 3 weeks ago

AI Match Score

Apply

Clinical Regulatory Writing Freyr

5.0 - 6.0 years

0 - 0 Lacs

Hyderabad

Remote

Description Primary Responsibilities: Drafting and/or content QC of Module 2.5 and 2.7 for INDs, NDAs, BLAs and other regulatory submissions. Drafting and/or content QC of clinical sections for Investigators Brochure (IB) and Briefing packages. Drafting and/or content QC of clinical study protocols and Clinical study reports (CSR) Perform Quality Check (QC) of clinical documents for consistency, accuracy of data and content. Assist in gap analysis of regulatory dossier. Verification of comment resolutions and taking up the document for finalization. Secondary Responsibilities: Participate and provide internal training on various technical matters/subjects. Any other responsibilities given by...

Posted 3 months ago

AI Match Score

Apply

Sr. Medical Writer - Regulatory Writing Gi Group

8.0 - 13.0 years

15 - 27 Lacs

Bengaluru

Work from Office

Job Title: Senior Medical Writer Regulatory Writing Education Requirements: MBBS / PhD / MDS / BDS / MPharm / PharmD/M.Sc/B.Pharma/B.Tech Location: Bangalore (Hybrid as applicable) Experience: 8 to12 years of experience in authoring clinical and regulatory documents supporting global filings, particularly CTD Module 2 and Module 5. Role Purpose: This role involves managing complex medical writing projects, reviewing regulatory deliverables, and mentoring junior writers. The position requires both strategic thinking and hands-on execution in support of global regulatory submissions. Key Responsibilities: Independently prepare and review regulatory documents such as clinical study reports (CSR...

Posted 3 months ago

AI Match Score

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.