Global Regulatory Services Head @ Bristol-Myers
Squibb is a global Biopharma company
Bristol-Myers
Squibb is a global Biopharma company committed to a single mission: to
discover, develop, and deliver innovative medicines focused on helping millions
of patients around the world in disease areas such as oncology, cardiovascular,
immunoscience and fibrosis.
Join us and
make a difference. We hire the best
people and provide them with a work environment that places a premium on
diversity, integrity, collaboration and personal development. Through a culture
of inclusion, we create a better, more productive work environment. We believe
that the diverse experiences and perspectives of all our employees help to
drive innovation and transformative business results.
The key
objective of this role is to drive Regulatory department performance in order
to deliver timely regulatory submissions (paper / electronic) and approvals,
while promoting integrity, transparency and proactive communication of
expectations to stakeholders, for regulatory activities like, but not
restricted to
New
drugs/biologics, subsequent new drugs/biologics, new/additional dosage
strengths/forms, manufacturing site, import license registration/renewal
registration; withdrawals, etc. for commercialized products
Post-approval
variations/amendments like CMC, CCDS (i.e. package inserts) and labelling,
manufacturing site, company registered address etc. for commercialized products
Study
protocol, protocol amendments, test license, investigation sites, periodic
study reports etc. for clinical trials
Health
Authority commitments and queries
Experience required:
Degree in
Pharmacy or in other Life Sciences,
5-10 years of
core functional regulatory knowledge an of which 3- 5 years of experience in
leading the country regulatory team
Exposure to
international regulatory environment and capability to adapt the regulatory
organization and implement appropriate plans.
Proven
experience and ability to manage people and cross functional groups
Demonstrated
track record of developing teams and creating working systems and processes
• Ability to negotiate
• Fluency in English
• Willingness to travel (approx.20%
of working time, to Delhi)
Please note
the posting is open up to 19/12/2019.
Bristol-Myers
Squibb recognizes the importance of balance and flexibility in our work
environment. We offer a wide variety of competitive benefits, services and
programs that provide our employees the resources to pursue their goals, both
at work and in their personal lives.
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