Otsuka Pharmaceutical Hiring Regulatory Affairs Process Incharge

Otsuka Pharmaceutical
Location: Ahmedabad
Job Vacancies: Regulatory Affairs Process Incharge
Required Education: B pharmacy M pharmacy
Departments: Regulatory Affairs

Walk-In Interview – Process Incharge at Otsuka Pharmaceutical India Pvt. Ltd., Ahmedabad

Join the dynamic team at Otsuka Pharmaceutical India Private Limited (OPI), a renowned Joint Venture between Otsuka Pharmaceutical Factory, Inc., Japan, and Mitsui & Co. Ltd., Japan. OPI is dedicated to the infusion business in India and emerging markets, with a commitment to manufacturing and marketing products across various therapeutic segments. As leaders in intravenous nutrition products, we are driven by our mission to be the preferred partner for patients and healthcare professionals in the field of clinical nutrition.

Vacancies List:

  • Company Name: Otsuka Pharmaceutical India Private Limited (OPI)
  • Location: Ahmedabad, Gujarat
  • Department: Regulatory Affairs
  • Position Title: Process Incharge
  • Experience: 2-7+ years
  • Qualification: B.Pharm, M.Pharm
  • Salary: 3-6 Lacs P.A.
  • Number of Openings: 03

Job Description:

Role & Responsibilities:

  • Dossier preparation/review as per country-specific guidelines/CTD guidelines.
  • Timely query response submission to Distributor/Ministry of Health (MOH).
  • Review of documents for correctness and compliance with respective regulatory guidelines (as per country requirements).
  • Preparation, review, and release of artworks and sales orders as per country approval.
  • Variation document preparation and filing as per country requirements.
  • Timely dispatch of tender documents to countries/parties as per deadlines.

Preferred Candidate Profile:

  • Ability to review and interpret requirements as per country-specific/tender guidelines.
  • Competence in reviewing various plant documents for dossier preparation, including Process validation, Stability study, PDR, Method validation, SOP, Drug Master file, BMR, APR, etc.
  • Capable of managing a team of two members.
  • Effective communication skills with relevant functions for procurement of required regulatory documents.
  • Ability to liaise with relevant counterparts in the country.
  • Preferably immediate joiners.

How to Apply:

If you meet the qualifications and are ready to take on this exciting role, we encourage you to attend our walk-in interview:

Date: 23rd September 2023

Time: 9:00 AM – 2:00 PM

Venue: Otsuka Pharmaceutical India Pvt. Ltd., 21st Floor, B Block, Westgate, near YMCA Club, SG Highway, Ahmedabad-380015, Gujarat

Contact: Himanshu (7984556557)

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