Hospira is the world's leading provider of injectable drugs and infusion technologies. Through our broad, integrated portfolio, we are uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs.
Through our offering of high-quality, lower-cost generic medications, we continue to help reduce the overall costs of healthcare — to improve both the affordability of care for patients and the financial strength of the global healthcare system.
Post : Regulatory Affairs (TAPS)
Job Description
- Day to day provision of general assistance to Strategists in the compilation of regulatory dossiers, coordination of marketing applications and responding to regulatory questions received from health authorities, as well as compilations of responses to queries that can serve multiple purposes
- Support for use of regulatory systems and managing documentation and information, including setting up standard formats or reports for recurring requests and status updates as needed.
- Support transition from RADARS to GDMS (archival system for regulatory documentation) and assurance of accuracy of metadata for documents
- Maintain Regulatory Product profile documents by updating as requested by strategist when key milestones occur. Including status of product indications supplement status per AG settlement
- Provide targeted documentation searches in RADARS/GDMS in support of responding to Health Authority queries and/or internal queries (such as AG settlement information search or searches to support medical information responses)
- Support for harmonization of Core Data Sheet (CDS) documents (multiple CDS per product) by preparing label comparison documents
- Complete data entry for PEARL updates as needed based on email template from PCOs
- Prepare and manage viewpoint items for planned submissions as needed
- Maintain tracking report for upcoming and pending approval submissions to facilitate communications with downstream team members such as Ad/Promo Regulatory, Commercial and PGS
- Prepare draft meeting notes and action item lists for Labeling and Rapid Response Team (RRT) meetings as needed.
Candidate Profile
Education: Post Graduate in Pharmacy or Science.
Skills: Required – excellent written, listening and verbal communication skills, ability to problem solve, technical aptitude ability to quickly learn and use new software, regulations and quality standards, attention to detail, ability to work independently with appropriate level of supervision, experience in customer service environment, aptitude in project management and logistics
Preferred – knowledge of regulatory processes and documents, knowledge of therapeutic areas.
Additional Information:
Auto req ID: 1614989
Qualification: M.Pharm, M.Sc
Location: Tamil Nadu
Functional Area: Regulatory Affairs
End Date: 20th October, 2017
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