SMP Support - EMEA - OTC - Pharma/Healthcare

Job Title: SMP Support for EMEA - OTC

Employment Type: Full time

Location: Bangalore, India

The SMP Support for EMEA position provides support to product portfolio through execution of regulatory activities to create / update Product Information File (EU) and maintain / update / renew of product registrations (non EU countries), Middle East and Africa regions. This individual- principal responsibilities include creation of regulatory documents, example ingredient list, regulatory clearance and providing regulatory review of product specifications, labeling. In this position, the SMP support for EAME will work with client's cross functional partners to provide regulatory inputs / documents along with inputs related to regulatory review of product information file. This position assists in preparing registration dossiers using regional data and liaising with manufacturing sites.

This position will enable to provide support to client's local market contacts in their registration procedure and complete market impact assessments.

Specific day to day responsibility of the SMP support for EMEA position includes, but not limited to:

- Ensure that standards and timelines are met

- Use of regulatory data base (Register) and IT tools (GSS, Optiva, Starfish...)

- Create and update working practices for processes used between Outsource partner & EMEA Regulatory Affairs, using a lessons learned approach

- Plan and track resource levels required and used for regulatory support requested.

- Life Science or Chemistry or Pharmacist Degree or equivalent qualification.

- Experience in European Regulatory Affairs for health products. Experience with Personal Care products would be desirable.

- Demonstrate excellent communication skills - both oral and written.

- Analytical thought

Well organized and rigorous