Regulatory Affairs CMC Manager India – Office or Home Based - Permanent @ ClinTec International "D"

Regulatory Affairs CMC Manager
Location:	India
Job Code:	CP-PM-INDIA-08052014
# of Openings:	1
Description
Regulatory Affairs CMC Manager – India – Office or Home Based - Permanent  ClinTec International is actively recruiting for a Regulatory Affairs CMC Manager to join our expanding global company in the India – this is a permanent, Home or Office based opportunity. By working for ClinTec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits. Responsibilities of the Regulatory Affairs CMC Manager: Monitor and develop continuous improvement proposals on the processes Oversee day-to-day activities Maintain a staff of adequately skilled resources to meet deliverables Communicate issues and resolve in an appropriate time frame Ensure adherence to agreed-to work practices Meet established submission timelines and quality standards Notify the sponsor of any change in resources to ensure a consistent approach to our work Participate, as needed, on global/local teams to complete assignments and tasks within a specific task force/project associated with submissions. Liaise with key interfaces on project requirements to ensure timelines are mutually understood Ensure collection of metrics required by the sponsor Essential Criteria: Bachelor’s degree, equivalent of higher qualification in a relevant life sciences discipline Significant track record within project management Excellent knowledge of the pharmaceutical product development process or manufacturing/improvement processes Advanced knowledge of global Chemistry Manufacturing and Controls (CMC) Ability to demonstrate strong commercial business acumen Ability to work to strict operational deadlines and manage conflicting priorities accordingly Excellent communication skills including the ability to interact and manage relationships with international colleagues and clients orally and in writing High level of IT literacy including use of Internet, email and Microsoft Office suite of packages Willingness and ability to travel internationally on a regular basis Fluency in English language (written and spoken) Willingness and ability to be office or home based in the India Desirable Criteria: Formal Project Management Training / Accreditation Company Information: ClinTec International is a UK-based, dynamic privately owned full service Contract Research Organization with a presence in over 43 countries worldwide.  We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries for over a decade and assist in their key product development efforts. At ClinTec International, we pride ourselves on delivering high quality, flexible and professional services/solutions for our clients.  ClinTec International has a wealth of experience in managing clinical trials in all major therapeutic areas including oncology, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology. ClinTec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process.  We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects - with the opportunity to develop, progress and travel globally. ClinTec International offers a competitive salary and rewards package.   APPLY