Gland Pharma – Urgent Openings for Regulatory Affairs Department – Apply Now
Gland Pharma Limited is Established in Hyderabad, India in 1978, Gland Pharma has grown over the years from a contract manufacturer of small volume liquid parenteral products, to become one of the largest and fastest growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India and other markets. We operate primarily under a business to business (B2B) model and have an excellent track record in the development, manufacturing and marketing of complex injectables.
Greetings 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 email@example.com
Mail Subject : Resume for DRA_ROW market.
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