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Kreative Organics - Executive - Regulatory Affairs (4-8 yrs)

Hyderabad Job Code: 16422

Designation: 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 cycle management,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 intermediates regulatory 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 flow

- Knowledge 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

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