Sr. Manager- Regulatory Affairs ( R &D ) @ Bangalore

Ideal Consultants - Hyderabad
  • Bangalore
  • Confidential
  • 12-15 years
  • 28 Jul 2015

  • Compliance/ Regulatory

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

M Pharma with 12 -15 years experience ( Europe, Australia, Japan market filing experience )
Good knowledge of regulatory pathways and options/strategy for Europe and others
Knowledge and experience of preparing Common Technical Documents and Clinical Trial Application dossier
Should prepare position papers for internal presentation to Management and Task force committee - strategy for registering the product in different markets, pros and cons, information on product related competitors in similar markets, licensing requirements and end to end understanding of regulatory procedures for registering a product in India, Europe and Rest of the world
Be able to manage the changes during the life cycle of the product
Should have understanding of GMP, GDP & GLPs
Knowledge of preparing eCTD (electronic Commercial Technical Documents)
Main focus will be on the development and execution of regulatory strategy for the assigned components of regulatory applications and submissions
Managing and coordinating various regulatory activities throughout the life cycle of the project/product
Additional focus will be on appropriate planning for prioritization and coordination of activities among functional areas and within Regulatory affairs, and for timely identification and communication of project/product related concerns to the Head- RA such that same can be addressed in a timely manner
The position is expected to organise and lead contacts with regulatory agencies and/or parent company
Should have excellent oral and written communication skills and presentation skills
Be able to manage Team.

Forward CV s: Call at 9849006750

Competencies/Skill sets for this job

Regulatory Affairs RA Life Cycle Technical Documentation

Job Posted By

Sudha .

About Organisation

Ideal Consultants - Hyderabad