Regulatory Affairs Specialist Project Lead I

Please share your resumes at kumar@vakulatech.com

Job Role: Regulatory Affairs Specialist Project Lead I

Location: Remote

Contract: W2

Accountable for leading the development and execution of

innovative and value-added global regulatory strategies and be responsible for

formulating the Global Regulatory Project Strategy (GRPS) for immunology

products in Early Development.

Leads the development of a Global Health Authority (HA)

interaction plan and strategy in collaboration with Global Regulatory Team (GRT)

and is accountable for the communication of the key outcomes to senior

management.

Education And Experience

• BS/BA degree in a relevant scientific discipline required. Advanced degree
  
  

(PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) is

preferred.

• At least 8-10 years of relevant pharmaceutical/biotechnology experience
  
  

in R&D, including at least 5 years of relevant Regulatory Affairs experience

(regionally and/or global), in early development.