Barrington James
Recruitment Consultant @BarringtonJames based in the USA | Connecting top Regulatory Affairs professionals with leading Pharmaceutical & Biotechnology…
We're looking for a
regulatory affairs director , to lead teams through major regulatory submissions and implement the programs regional/global strategy.
Responsibilities
Shape and drive regional/global regulatory plans and strategy that supports fast approvals differentiated labelling consistent with commercial goals, market needs and patients benefits
Lead cross-functional teams in large regulatory submissions (NDA/IND/CTA/BLA), through HA interactions, labeling discussions and securing approvals
Design and execute the strategy + engagement plan with HAs
Lead a GRST team of key contributing members from the relevant regions, emerging markets, RA CMC, Labelling and other members of the submission and execution team
Requirements
Bachelor's degree in a science related field with at least 3 years of Regulatory strategy or related knowledge/experience.
Experience in Oncology (small molecules & biologics) is preferred.
Previous demonstrated experience of regulatory drug development or equivalent, and experience with major HA interactions.
Compensation
Competitive base salary and bonus scheme
Generous 401K plan
Short and long term bonus incentives
Health benefits (Medical, Prescription drug, dental and vision)
If you think this role is for you, apply and someone will be in touch.
Seniority Level Director
Employment Type Full-time
Job Function Science
Benefits
Medical insurance
Vision insurance
401(k)
Pension plan
Child care support
Paid maternity leave
Paid paternity leave
Student loan assistance
Tuition assistance
Disability insurance
#J-18808-Ljbffr
We're looking for a
regulatory affairs director , to lead teams through major regulatory submissions and implement the programs regional/global strategy.
Responsibilities
Shape and drive regional/global regulatory plans and strategy that supports fast approvals differentiated labelling consistent with commercial goals, market needs and patients benefits
Lead cross-functional teams in large regulatory submissions (NDA/IND/CTA/BLA), through HA interactions, labeling discussions and securing approvals
Design and execute the strategy + engagement plan with HAs
Lead a GRST team of key contributing members from the relevant regions, emerging markets, RA CMC, Labelling and other members of the submission and execution team
Requirements
Bachelor's degree in a science related field with at least 3 years of Regulatory strategy or related knowledge/experience.
Experience in Oncology (small molecules & biologics) is preferred.
Previous demonstrated experience of regulatory drug development or equivalent, and experience with major HA interactions.
Compensation
Competitive base salary and bonus scheme
Generous 401K plan
Short and long term bonus incentives
Health benefits (Medical, Prescription drug, dental and vision)
If you think this role is for you, apply and someone will be in touch.
Seniority Level Director
Employment Type Full-time
Job Function Science
Benefits
Medical insurance
Vision insurance
401(k)
Pension plan
Child care support
Paid maternity leave
Paid paternity leave
Student loan assistance
Tuition assistance
Disability insurance
#J-18808-Ljbffr