Home / B.Pharm / Regulatory Affairs Manager @ Claris Lifesciences Ltd | Rs. 7 Lakh PA Salary Package

Regulatory Affairs Manager @ Claris Lifesciences Ltd | Rs. 7 Lakh PA Salary Package

Claris Lifesciences Limited
Claris Lifesciences Limited, a BSE listed company, is a multi-business enterprise and the Holding Company of Claris Injectables – a wholly-owned subsidiary dealing in Specialty Injectables business, collectively  and Claris Otsuka – a Joint Venture with Japanese Otsuka Pharmaceutical Factory, Inc. & Mitsui & Co. Ltd. for Infusion business in India & Emerging Markets.

Job Title  Regulatory Affairs Manager

No. of Posts 2

Salary:  INR 3,00,000 – 7,00,000 P.A.

Job Description:

  • To understand and refer the country specific regulatory requirements for product registration application.
  • To obtain required data/information/document from inter-functions for dossier/query response/variation preparation.
  • To review & finalize the received technical information from inter-functions to ensure regulatory compliance as per guidance & ICH guidelines.
  • Preparation and submission of dossier in accordance with country specific requirement and ICH, to Partner / Authority.
  • To handle regulatory queries arising from regulatory partner/authorities and respond it in committed timeframe.
  • To prepare the variation application as per county specific guideline for received affected change cases.
  • Preparation of Artworks for commercial / registration purpose.
  • To work closely with local regulatory associates / authority for allocated projects.
  • To follow IRA internal SOPs for each allocated activities and record the respective activities in defined logbooks/internal files.
  • Review of APR against the approved information to finalize regulatory data in APR.

Qualifications

  • The candidate must have
    • 3 – 6 years of experience in IRA department, preferably in injectable products
    • Sound knowledge of ICH guideline
  • Educational Qualifications : B. Pharma / M. Pharma
  • Personal Attributes and skills : The candidate should have
    • Good communication and interpersonal skills,
    • Ability to manage multiple responsibilities
    • Attention to details and team player

View Notification

About Rainer Kim

Leave a Reply

Your email address will not be published. Required fields are marked *