Manager - Regulatory Affairs

The world’s leading pharmaceutical services company is looking for a Regulatory Affairs Manager. The company operates across the globe and is the world's leading Contract Research Organisation.
Location: Mumbai
Job Profile:
To lead the regulatory affairs team independently on any type of writing or technical project.
Take initiative to generate new and unusual document types to meet customer requirements of  various countries as per global regulatory requirements.
Ensure the review and compilation of documents to be submitted to regulatory agencies.
Ensure the compliance with regulatory processes, ensuring readiness for internal or external project audits.
Be Proactive to review documents and data generated for anticipated queries and ensure quick response to queries received from different regulatory bodies and customer to expedite the approval process.
Provide training to the team members.
Performs other tasks or assignments, as delegated by Regulatory management.
Candidate’s profile:
Degree in life science-related discipline or professional equivalent.
Experience:
At least 6 years relevant experience in regulatory affairs in Regulated Markets or India
Advanced negotiating and influencing skills and the ability to identify and resolve issues.
Strong software and computer skills, including MS Office applications
Understanding the implications of new information for both current and future problem-solving and decision-making.
Managing one's own time and the time of others

This position, Manager - Regulatory Affairs, was posted on April 2, 2010. The job is located in Mumbai. Since this job has been published, it has been viewed 57 times.