HomeRegulatory AffairsOfficer Regulatory Affairs (CIS) | Otsuka Pharmaceuticals | Ahmedabad | 3.00-4.00 L

Officer Regulatory Affairs (CIS) | Otsuka Pharmaceuticals | Ahmedabad | 3.00-4.00 L

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Otsuka Pharmaceutical India Private Limited (OPI) resolutely believes in keeping its employees happy and spirited. We always strive to build conducive and lasting relationships with our employees and drive them in the direction of the utmost growth and development. Though oceans and desserts apart, all the Otsuka-people – a vigorous group of diverse professionals, are bound by a close-knit culture and driven by a common vision, sharing a common goal – bettering lives worldwide.

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Life at OPI goes beyond the realms of a routine job. Work is not about simply earning handsome salaries at OPI. It’s about being challenged every day, overcoming them, earning rewards, and achieving the biggest virtue of an employee, ‘Job satisfaction’. We encourage our people to broaden their horizon and steer their career in the direction of prosperity and success.

Training & Development, Engagement & Involvement form the foundational credo at OPI. Moreover, we keep our members engaged and motivated by inducing a value-based culture replete with youthfulness, openness, exuberance, goal-orientation, responsibility, excellence, ethics, pride to name a few by dint of our workplace practices.

Position: Officer Regulatory Affairs

Location: Ahmedabad, Gujarat, India

Job Description:

  • Dossier preparation as per country-specific guideline/CTD guideline
  • Timely query response submission to Distributor/ MOH
  • Review of documents for its correctness and compliance with respective regulatory guidelines (as per country requirement)
  • Preparation, review & release of artworks & sales order as per country approval
  • Variation documents preparation and filing as per country requirements
  • Timely dispatch of tender documents to country/parties as per the deadline

Desired Candidate Profile:

  • Should be able to review & interpret the requirement as per country-specific guideline
  • Should be able to review various plant documents for dossier preparation like Process Validation, Stability study, PDR, Method validation, SOP, Drug Master file, BMR, APR, etc.
  • Should be able to communicate with relevant functions for procurement of required regulatory documents
  • Should be able to communicate with a relevant counterpart in-country
  • Preferred candidates having experience in the CIS Region.

Qualification: B.Pharma/M.Pharma

Experience: 2-3 Years

Salary: 3,00,000 to 4,00,000 INR CTC/PA

Contact Details:

Mr. Sekhar Sharma

hrm.opmf-amd@otsukapharma.in, sekhar.sharma@otsukapharma.in

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