- Preparation, compilation & submission of Dossiers in CTD, ACTD as well as country specific format For African, Southeast Asian, and Latin America countries like. Kenya, Nigeria, Ghana, Philippines, Myanmar, Vietnam, Sri Lanka, Cambodia, Guyana, Guatemala, EL Salvador, Tanzania, Syria, Yemen etc.
- Responding to technical queries related to product registration.
- Evaluation and preparation of post approval supplements to manage the regulatory product as applicable.
- Coordinate and consult with other department for accurate and timely assembly of regulatory document for submissions.
- Knowledge of New Product Development.
- Reviewing technical documents and checking of Artworks as per the countries guidelines.
- Co-ordination with International Customers
- Technical data support to dossier preparation for UK.
- Replying to product based queries on the basis of clinical studies asked by medical fraternity.
- Keeping up-to-date with changes in regulatory legislation and guidelines
- Candidate should have a pleasing personality with good command on written and spoken English. Candidate should have good interpersonal skills.Should be a self starter, takes initiative. Aggressive with go-getter attitude to drive the business.
Recruiter Name:Ms. Apurva Jadhav
Email Address:hrmum@meyer.co.in
Website:https://www.meyer.co.in
Telephone:91-22-25817000
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