Regulatory Affairs officer

Responsible to prepare and review of dossier as per CTD / ACTD / Country specific guidelines

Responsible for dossier compilation and query response

Co-ordination with Cross-Functional Team and Business Partners

To prepare and review all technical documents (SPEC, BMR, MFR, Validation reports etc)

Proficiency in literature search for products at various stage of R&D.

Ability to conduct secondary research and acquire information from internet sources, journals, public databases, etc.

Experienced and good hand-on drafting Clinical & non-clinical overview/summary.

Required knowledge of toxicity studies, BA-BE studies and clinical trials.

Working on regulatory agencies regarding

Pre-submission strategies, potential regulatory pathways.

Review of documents to ensure there are no gaps

Maintains the highest level of submission standards.

Maintains familiarity with evolving and/or new regulatory e-submission requirements maintains the highest level of submission standards.

Maintains familiarity with evolving and/or new regulatory e-submission requirements

Familiarization with evolving guidance of Row markets

Job Type: Full-time

Education:

• Master's (Preferred)

Experience:

• total work: 1 year (Preferred)

Work Location: In person