Gland Pharma Hiring For Regulatory Affairs Department
Job Vacancy at from Gland Pharma Ltd!!!
We have a vacant position in Regulatory Affairs (RA) department for ROW market.
Designation : Manager / Sr. Manager.
Experience : 12-15 Years
Qualification B. Pharmacy / M. Pharmacy
Location: Hyderabad
Required Skills:
1. Regulatory activities specifically related to chemistry, manufacturing, and control (CMC) of parenteral / Injectables.
2. Identify the required documentation and any content, quality and timelines issues for regulatory submissions across emerging markets and negotiate the delivery of approved technical source documents in accordance with project timelines.
3. Author and/or review high-quality CMC documentation for submission, applying agreed CMC regulatory strategies, current regulatory trends and guidelines.
4. Communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner with project teams and other stakeholders to ensure regulatory compliance.
5. Prepare and communicate CMC Risk Management Assessments, contingency plans and lessons learned on major submissions and escalate with management as appropriate. 6. Developing monthly & quarterly execution plan for team molecules to ensure 100% timely submission and monitoring day to day work allocation etc...
Interested one can share their updated resumes to hr@glandpharma.com
Mail Subject: Resume for DRA_ROW market.
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