Regulatory Affairs Specialist

11 hours ago

Mumbai, Maharashtra, India Easebiz Fintech Solutions Full time ₹ 15,00,000 - ₹ 25,00,000 per year

One of our client based at Mumbai (Reputed MNC Company) is looking for below positions

Role & responsibilities

1. Asst Manager / Manager/Sr. Manager - Biologics Regulatory Affairs (Clinical Trials)-2 positions

Job Location: Govandi (East ), Mumbai (alternate Saturday working)

Desired Qualification: M.Pharm/B.Pharm

Desired Work Experience: 5-10 years

Job Responsibilities:

  1. Biosimilar Clinical Development Strategy.

  2. Biosimilar Clinical design and Protocol development, review and finalization.

  3. Biosimilar Clinical Trial Application, Overview of clinical study conduct, Clinical Study report review and finalization.

  4. Biologics/Biosimilar Dossier Authoring, Review and Hands-on experience in eCTD submissions. 5. MOH Query response.

  5. Product Life cycle Management.

  6. RA support for Plant related QMS activities.

2. Asst Manager / Manager /Sr. Manager- Biologics Regulatory Affairs (CMC)-2 openings

Job Location: Govandi (East ), Mumbai (alternate Saturday working)

Desired Qualification: M.Pharm/B.Pharm

Desired Work Experience: 5-10 years

Job Responsibilities:

  1. Biosimilar Regulated market submissions - US / EU injectable market submission.

  2. Biosimilar Product Development Strategy for CMC and Clinical.

  3. Review of all Dossier related Quality documents including coordination with Cross functional teams ( R&D, QC/QA and Manufacturing).

  4. Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions.

  5. MOH Query response.

  6. Biosimilar Product Life Cycle Management.

  7. RA support for Plant related QMS activities.

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