Regulatory Affairs Executive / Officer

By: Pharma Jobs | Views: 7768 | Date: 14-May-2011

Candidate have relavance experience of regulatory affairs in regulated market preferable in Injectable formulation.

Claris Lifesciences Limited



2 - 5 Years




UG - B.Pharma - Pharmacy,B.Sc - Any Specialization PG - M.Pharma - Pharmacy,M.Sc - Any Specialization

Industry Type:

Pharma/ Biotech/Clinical Research


Regulatory Affairs Mgr

Functional Area:

Healthcare, Medical, R&D

Posted Date:

04 May

Desired Candidate Profile

  • Candidate have relavance experience of regulatory affairs in regulated market preferable in Injectable formulation.

Job Description

  • Verifying the technical documents for product planned for registration as per the relevant checklist or guidelines.
  • Compiling & formatting technical documents for Dossier preparation in the CTD format.
  • Verifying dossier / documents before submissions for it’s correctness and completeness.
  • Handling (receipt and responding) product related regulatory or customer queries.
  • Following the Standard Operating Procedure for document handling and maintenance.
  • Execute the weekly and monthly plans to ensure annual targets are achieved for both submissions and approvals.
  • Preparing and sending out project progress reports and raising early alarms on issues that might delay approvals.
  • Representing the regulatory function during cGMP and Safety inspections.
Keywords: IRA, Regulatory Affairs, Regulated Market

Company Profile

Claris Lifesciences is an IPR driven international pharmaceutical company, in the business of manufacturing and marketing of high end injectables with focus on New Drug Delivery Systems for treatment of critical illnesses and diseases.

With emphasis on Quality, Technology & Innovation, Claris offers a range of niche technology Aqueous & Lipid emulsion injectable products across delivery systems such as bottles, vials, ampoules, non-PVC/PVC bags . The company's strength lies in its know-how and expertise in manufacturing and marketing injectable products.

Driven by a team of scientists, pharmaceutical experts and management professionals, Claris is powered by a combination of Vision, R&D capabilities, Technological know-how, International standards and Manufacturing expertise , an expanded Proprietary Marketing Network and Ambition to be one of the world’s leading and most admired pharmaceutical companies in the global generics space.

The company's range of products and delivery systems extends across Enteral and Parenteral Nutrition, Anaesthesia, Blood Products and Plasma Volume Expanders, Anti-infectives, Dialysis and Transplant, Oncology & Infusion Therapy.

Claris enjoys Market Leadership in India. Globally, the company operates in more than 76 countries, through its subsidiaries, offices and marketing/distribution network, and a diverse customer profile covering institutions, large corporate hospitals and international aid agencies.
Contact Details
Company Name:

Claris Lifesciences Limited

Executive Name:

Rajendra Panchal


Claris Lifesciences Limited
Corporate Towers, Near Parimal Railway Crossing
AHMEDABAD,Gujarat,India 380006



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