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Vacancy as Head of Regulatory Affairs, Quality & Pharmacovigilance in Novo Nordisk

 

Clinical courses

Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190 countries Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B).

Post: Head of Regulatory Affairs, Quality & Pharmacovigilance, India

Job Desciption
As Head of Regulatory Affairs, Quality and Pharmacovigilance, you will be managing regulatory activities for clinical trials, which includes submission and review processes as per requirements. You will be responsible for regulatory safety reporting and managing new product registrations in India region. You will be providing inputs and finalise local registration strategies and implementation plans for new products. Submission, approval/notification of STF updates including approval of new indications, safety or label updates within applicable timelines. Developing and Maintaining IT repository, safety Sop and regulatory manual. Keeping up to date with current regulatory & quality requirements/regulations, participate in development of new regulations for India. Ensuring completion of Quality Activity Plan within timelines; and provide oversight for managing clinical quality & training activities for Clinical Operations in close collaboration with Head-Clinical Operations.

You will demonstrate excellent communication skills both internally and externally for the successful implementation of your main deliverables. You will be required to effectively lead and manage people in the Regulatory, Quality and Pharmacovigilance functions.


Qualifications
You need to have a minimum a completed university degree in Science, Pharmacy; however post-graduate in Pharmacy/ Pharmacology/Science will be preferred. You must have as a minimum 4 years of experience as people manager and overall at least 8-10 years’ experience, with significant regulatory experience.
You need to have strong analytical skills, demonstrate strong cross functional collaboration and team work. You should have good decision making and problem solving ability, demonstrate agility in ways of working and further be able to motivate the team and drive performance. You should have great communication (verbal and written), good planning and organizational skills, project management skills and proven excellence in regulatory activities.

Headquartered in Denmark, Novo Nordisk is a global healthcare company with 91 years of innovation and leadership in diabetes care and has leading positions within haemophilia care, growth hormone and hormone replacement therapies. Novo Nordisk markets its products in over 180 countries and has been operating in South Africa since 1959. Novo Nordisk has a broad portfolio of treatments, a strong pipe-line and a determination to go beyond medicine and strongly advocates for better healthcare and health initiatives to positively impact the lives of people living with chronic conditions. Through Changing Diabetes® and Changing Possibilities in Haemophilia®, our program.
At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.


Additional Information:
Qualification: M.Pharm, M.Sc
Location: Bangalore

Industry Type: Pharma/ Biotech/Clinical Research
Functional Area:  Pharmacovigilance

Post Date: 31st August, 2015

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