About Ferring:By building strong relationships within the scientific community, our medical affairs team has become a trusted partner among patient groups, clinicians and health policy decision makers. We pride ourselves on developing and disseminating information to our key stakeholders so that they can provide the best care for our patients. Because we oversee the entire lifecycle for many of our products, we’re on the forefront of developing valuable and scientifically grounded information that will chart exciting paths forward for many of our innovative brands. Join our expert team and drive innovation.Job Description:
Supports the Regulatory Operations Team in the creation of regulatory submissions in their delivery of regulatory submission components
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Assist regulatory in preparation, formatting, and internal approval of QA documents for new product.
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Coordination with related Official Departments or authorities. i.e. Health Authorities worldwide
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Create and updating of related SOPs, cooperate with related departments including monitor the implementation of SOPs
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Monitor the regulatory status for variation worldwide and coordinate with staff in other countries
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Update GRA table and archiving correspondence to Health Authorities.
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Develop regulatory network between different departments and other countries
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Prepare annual product quality report, product-related quality (PQRS / APRs) report
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Coordinate with other group/department and related third parties in part of product quality and statistical process control
- Statistical analysis using Minitab or equivalent tools
• Commercial diploma or equivalent • Minimum 2 years experience in Regulatory Affairs • Microsoft office and regulatory data base • Good command in English • Ability to handle several tasks
Location:Ferring India Production
What We Do
Ferring Pharmaceuticals is a privately owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine and maternal health, and in areas of gastroenterology and urology. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Ferring was founded in 1950 and employs more than 7,000 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which markets its medicines in over 100 countries.
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