Clarivate Analytics is the global leader in providing trusted insights and analytics to accelerate the pace of innovation. Building on a heritage going back more than a century and a half, we have built some of the most trusted brands across the innovation lifecycle, including Web of Science, Cortellis, Derwent, CompuMark, MarkMonitor and Techstreet. Today, Clarivate Analytics is a new and independent company on a bold entrepreneurial mission to help our clients radically reduce the time from new ideas to life-changing innovations.
Post : Regulatory Editor, Cortellis CMC Expert
Duties and responsibilities:
1.Development of CMC regulatory database content & maintenance of content
• Actively participate in CMC content development as per specifications and project schedule, acting as internal expert for a set of countries
• Monitor changes and evolution of CMC regulatory landscape worldwide
• Analyze the changes in CMC requirements and implement changes in the database capitalizing on internal expertise and external network of consultants for local expertise and practice
2.Administrative tasks
• Participate in research to identify local CMC experts, negotiation of contract terms and negotiate copyrights when needed, budget follow-up and monitoring.
3. Customers/internal support
• Provide support to CMC Product Manager
• Provide customer support and expertise
• Communicate relevant information to concerned stakeholders.
Candidate Profile
• Minimum BS degree in Life Sciences
• 4-8 years’ experience in Pharmaceutical development or CMC manufacturing within a Pharma company
• 2-3 years’s experience in CMC regulatory affairs
• Strong knowledge of ICH requirements for quality aspects - Experience in Biologics would be a plus
• Strong experience in low regulated markets. Profiles with diverse market experiences will be preferred for this role.
• Working experience with FDA or EMA needed as well
• Experience working with teams globally
• Demonstrated ability to work collaboratively and resolve conflict across different functional areas in a highly matrixed organization.
• Good problem solver and able to demonstrate good judgment in decision making and setting priorities.
• Capability to work remotely with peers in an international environment
• Team spirit and good communication skills.
• Fluent in English. Another language appreciated.
• Travel requirements for this position is limited to 5%
• Minimum BS degree in Life Sciences
• 4-8 years’ experience in Pharmaceutical development or CMC manufacturing within a Pharma company
• 2-3 years’s experience in CMC regulatory affairs
• Strong knowledge of ICH requirements for quality aspects - Experience in Biologics would be a plus
• Strong experience in low regulated markets. Profiles with diverse market experiences will be preferred for this role.
• Working experience with FDA or EMA needed as well
• Experience working with teams globally
• Demonstrated ability to work collaboratively and resolve conflict across different functional areas in a highly matrixed organization.
• Good problem solver and able to demonstrate good judgment in decision making and setting priorities.
• Capability to work remotely with peers in an international environment
• Team spirit and good communication skills.
• Fluent in English. Another language appreciated.
• Travel requirements for this position is limited to 5%
Additional Information:
Experience: 2-8 years
Qualification : BS degree in Life Sciences
Location : Hyderabad / Bangalore
Industry Type: Pharma / Healthcare / Clinical research
Functional Area: Cortellis CMC Expert
Job ID: JREQ101385
Last Date: 30th July, 2018
Experience: 2-8 years
Qualification : BS degree in Life Sciences
Location : Hyderabad / Bangalore
Industry Type: Pharma / Healthcare / Clinical research
Functional Area: Cortellis CMC Expert
Job ID: JREQ101385
Last Date: 30th July, 2018
Share:
0 comments:
Post a Comment