Regulatory Affairs Job Vacancies in Hyderabad

We are urgently looking for Executive Regulatory Affairs . Handling of queries , CoPP , LOAs, Mockups, Handling of GS

After 45 days of free training (technical) followed by 15 days (non technical), candidates can be placed in pharma company. During training candidate need to take care of living expenses including food accomodation and local travel.

Kreative Organics Private Limited is a manufacturer of Active Pharmaceutical Ingredients (APIs) for the world market. Kreative started operations in 1990. Kreative was established by Dr. S. Krishnamohan. Dr. Krishnamohan was formerly with TIFR, BARC, Caltech and NASA. He is a scientist of international repute and runs Kreative with professionalism and a focus on innovation.Kreative maintains strict quality standards and has developed a robust quality system around which all of our products are manufactured.Kreative invested in a state of the art cGMP facility in 2005 and expanded it to a US FDA class facility in 2013.Kreative, is WHO GMP certified and has been successfully been audited by the US FDA in Feb 2020.

We are Urgently Looking for Regulatory Affairs Executive. Assisting Role in Ra Team and Responsible to Filings,

Candidates with working experience in Plastic Packaging are preferred

Every Day 3 to 5 Hours Classes .if Online Can Be Taken Class from Your Own Place

Designation: Sr. Officer / Executive/ Sr. Executive (Regulatory Affairs USA, EU, JAPAN,ANVISA, TGA market)Experience:- 3 to 6 years' work experience in international and domestic Pharma regulatory affairs.- Confirmed knowledge of Global market regulatory requirements and ICH guidelines.- Should have experience in eCTD DMF/Dossier preparation and review including life cyclemanagement, specifically CMC writing & preparing module 1, 2 and 3 previously.- Should have experience in handling of changes notification to customers and agencies- Should have experience in renewal of facility registrations and drug listing activities.- He/she has to work independently. There is no scope for supervision or team handling.- Only M.Sc Chemistry preferably or complete experience in API industry for BPharm /MPharm .Job Responsibilities:- Preparing DMF/dossiers for regulated and semi-regulated markets.- Preparation of documents for domestic license permissions.- Gathering, evaluating, organizing and managing drug substances and intermediatesregulatory information in a variety of formats.- Handling of change notifications with the customers and regulatory agencies- Maintaining Regulatory database up to date.- Address customer complaints and queries within agreed timelines.- Attending various customer and health authority audits held at the manufacturing site- Keeping up-to-date with changes in regulatory legislation and guidelines- Writing comprehensible, user-friendly, clear process description and impurity profile- Ensuring that high quality standards are met and submissions meet strict deadlines.Primary Skills:Understanding on API process and analytical methods development flowKnowledge on impurity profile, analytical method validations and stability studies.Knowledge on eCTD submission structure.Fluency in oral and written English.Able to build and maintain good communication with cross functional departments