Candidate have relavance experience of regulatory affairs in regulated market preferable in Injectable formulation.
Claris Lifesciences Limited
Summary
Education: UG - B.Pharma - Pharmacy,B.Sc - Any Specialization PG - M.Pharma - Pharmacy,M.Sc - Any Specialization
Industry Type: Pharma/ Biotech/Clinical Research
Role: Regulatory Affairs Mgr
Functional Area: Healthcare, Medical, R&D
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
Address: Claris Lifesciences Limited
Corporate Towers, Near Parimal Railway Crossing
Ellisbridge
AHMEDABAD,Gujarat,India 380006
Telephone: 91-79-26563331