Regulatory Scientist

From 2 to 7 year(s) of experience
₹ Not Disclosed by Recruiter

Job Description

Roles and Responsibilities

1. Responsible for Dossier compilation:

  • To prepare New, Renewal dossier and variations (Site/ Formula) of South Asia, LATAM countries and having specific knowledge for China, South Africa and Brazil filing and Regulatory knowledge of Guidelines viz, ICH , FDA PICs etc.
  • To review accuracy of executed data before submission - Plant generated validation reports and raw data as required to ensure compliance before Dossier submission.
  • To review of documents for adequacy and accuracy.
  • To ensure regulatory compliance and liaison with countries / regulatory authorities during the product registration process.
  • To arrange the samples as per country requirements.

2. Responsible for Tender compilation:

  • To gather, evaluate, organize, manage and collate information/ documents requirements for Tender fillings for WHO/UNICEF/MSF

3. Ensure timely delivery of regulatory query:

  • To review and ensure accuracy of deficiency response for Quality , Clinical part of dossier.
  • To evaluate the query received for registered or under registration products and Tender products and also to support for completion of the same in timely manner.

4. Other activities:

  • To maintain Data Bank for Commercial activity.
  • To work with quality standards and adherence to system.

5. Compliance (Audits / Audit Readiness)

  • Support in Site Audit Readiness and Compliance relevant to RA functions / procedures based on external / internal audits.
  • To Audit Alkem sites to verify the executed documents (Process validation Protocol and reports and BMRs/BPRs) and its accuracy and readiness as per GDP and GMP norms.

Role:Regulatory Affairs Compliance

Salary: Not Disclosed by Recruiter

Industry:Pharmaceutical & Life Sciences

Functional Area:Legal & Regulatory

Role Category:Corporate Affairs

Employment Type:Full Time, Permanent

Key Skills
Skills highlighted with ‘‘ are preferred keyskills


PG:M.Pharma in Any Specialization

Company Profile

Alkem Laboratories

Alkem Laboratories Ltd

Company Info
View Contact Details+

Contact Company:Alkem Laboratories

Address:Alkem Laboratories Ltd (R&D), C-6/1 C-6/2 C-17/7, Dist, Industrial Estate, Taloja Police Station,Taloja, Navi Mumbai, Maharashtra 410208