RA Executive/Asst.Manager

Kreative Organics Private Limited

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 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 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

Experience : 3 - 9 Years

No. of Openings : 02

Education : B.Pharma, B.Sc, M.Pharma, M.Sc

Role : RA Executive

Industry Type : Hospitals / Medical / Healthcare Equipments

Gender : Male

Job Country : India