QIAGEN is the leading provider of sample and assay technologies. Sample technologies are used to isolate DNA, RNA, and proteins from any biological sample. Assay technologies are then used to make specific target biomolecules, such as the DNA of a specific virus, visible for subsequent analysis.
We have developed and market more than 500 consumable products and automated solutions. The company provides these products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN's assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the digene HPV Test, which is regarded as a "gold standard" in testing for high-risk types of human papillomavirus (HPV), the primary cause of cervical cancer, as well as a broad suite of solutions for infectious disease testing and companion diagnostics. QIAGEN employs more than 3,500 people in over 35 locations worldwide.
Post: Manager, Regulatory Affairs, India
Job Description:
-Prepare, follow-up and maintain country specific registration files (new registration applications, renewals, and registration changes) and to report to regional and GLOBAL management departments
-To establish and maintain an appropriate reporting mechanism of registration information in order to maintain up to date details for reporting to local and global management in a timely manner.
-Research and interpret local regulations, guidelines and precedents and identify issues that may increase regulatory risks and propose strategies to address such risks
-Interface with regulatory agencies for inquiries and issues and represent QIAGEN when dealing with these agencies
Assess clinical protocols, R&D protocols and other company documents when applicable (including labeling and marketing materials) for regulatory impact or issues
-Plan and coordinate local clinical or evaluation studies as required to support local registrations.
-Work closely with the countries in the Asia-Pacific region to ensure a defined processes is in place to support local registration needs and activities ( includes working with the local affiliates and distributors or identifying and working with contract personnel)
-Provide regulatory support for Global RA, R&D, Production, Marketing and Sales functions of the company and coordinate with the local/regional functions in order to achieve strategic plan of company
- Identify need for SOPs relevant for registration of IVD products or other regulatory issues and is responsible for their development
Desired Profile:
Regulatory Affairs Experience 5+ years experience in Regulatory Affairs, RAC preferred. At least 3 years experience with Medical Device regulations regarding the import and registration of IVDs in India. Demonstrated success in the management of regulatory submission activities. Strong leadership skills with supervisory/management experience and demonstrated ability to interact professionally with governmental agencies and peers. Ability to work on complex problems and exercise independent decision making in developing regulatory strategies and solutions to regulatory problems. Excellent organizational skills with attention to detail and written and oral communication skills.
Additional Information:
Experience: 3-5 years
Location: Delhi
Education: B.Sc, M.Sc-biochem
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Email your resume or for any info, India-HR@qiagen.com
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