Lead Expert - Regulatory Affairs - IDMP - Healthcare

Industry - Pharma / Biotech / Clinical Research

Category - Operations

Skills - IDMP-Regulatory Operations

Job Type - Permanent

Job Description - Leading and executing the IDMP strategy by partnering with the Global Regulatory teams and also leading data management activities.

Client Details

The client is 350 years legacy player in the Healthcare space working across therapy areas like Oncology, Fertility and Neurology working globally across six continents.

Description

- IDMP operational strategy- Leading and execution

- Contribute to operational strategy input and be accountable for quality of the operational deliverable

- Basis the data entry guidances and systems functionalities, contribute to the documentation and training creation

- Lead all the data management activities like O and R (IDMP related)

- Responsible for providing the training, support and also the end user communication for data management topics and also on IDMP intelligence

- The role will be an IC role

Profile

- Candidate must have atleast 10 years of experience in Regulatory Affairs

- Candidate should be an SME in IDMP

- Candidate should have a strong understanding of the Regulatory Affairs business processes

- Candidate must have worked on end-to-end implementation of both systems (e.g.RIMS,DMS, SAP) and processes (e.g.xEVMPD)

- Candidates should have basic degree in a scientific discipline

Job Offer

An opportunity to work with leading MNC that believes in empowering the ambitions of their employees by providing them opportunities to seek new horizons

To apply online please click the 'Apply' button below.
For a confidential discussion about this role please contact Srividya Mukunthan on +91 22 4236 3304.

Contact - Srividya Mukunthan - +91 22 4236 3304

The Apply Button will redirect you to website. Please apply there as well.