Head - Legal & Compliance - LLB - Healthcare/Pharma

Job Designation : Head - Legal & Compliance

Qualification : LLB

Experience : 10 to 15 years

Location : Mumbai

Reporting To : Head- Business Unit

Job Responsibilities :

Legal & Compliance :

- Support Business Areas and Service Functions in all legal matters, in particular in competition law and intellectual property issues

- Manage contract process and provides respective templates

- Handle engagement of external legal counsels

- Handle any Litigation/ Investigation

- Coordinate with Head Legal APAC on key local legal issues (DOA)

- Ensure that Group Compliance Policies and Guidelines are implemented locally

- Support and/or conduct compliance monitoring, compliance controls and compliance audits

- Support Compliance Risk Management & Compliance Assurance

- Ensure Compliance Monitoring, Controls and Audits in the area of business integrity and obtain assurance declaration on business compliance from local managers.

- Responsible for Speak up Encouragement for all employees at RDC.

Local Compliance Officer :

- Ensuring that employees know where they can ask for help & advice if they have doubts about the correct business behavior;

- Networking and collaborating with local, regional and global compliance experts in order to identify and take advantages of synergies between Pharmaceuticals and Diagnostics;

- Coordinating local compliance endeavors, initiatives and training programs;

- Supporting and conducting compliance monitoring, compliance controls and compliance audits;

- Supporting Line Management in the local integrity risk-management processes;

- Supporting Line Management in the adequate handling of local non-compliance cases,

- Including reporting in the Business Ethics Incident Reporting (BEIR) system;

- Encouraging employees to speak up if they have a compliance concern

Affiliate Quality Head :

- Responsible to direct responsibility of any of Q&R main task.

- Ensure Divisional Quality Standards are incorporated into local procedures and staff is trained

- Monitor and ensure implementation of certain metrics/Key Performance Indicators (KPIs)

Product Quality & Safety Manager :

- Responsible to take care of Safety Board matters /Recalls/ Corrective Field Actions & notifies global functions

- Maintain local process for Complaints & trains staff on complaint handling

- Monitor Supply Chain Quality

- Training & Communication of local processes in line with Divisional Standards

Regulatory Affairs :

- Own the submission process & acts as primary contact for the Regulatory Authority

- Regulatory Intelligence to support regulatory strategy/opinions

- Support Quality (e.g. in labeling), provides trainings and ensures compliance with Divisional Standards

If interested kindly revert with following details :

Experience:
Current CTC:
Notice Period:

Name: Shilpa Nair
Mob: 8879252777
Tel: +91-22-25476846/7/9