What are the responsibilities and job description for the Regulatory Affairs Executive position at Jobleads-US?
Regulatory Strategy Executive
We are seeking a highly skilled Regulatory Affairs professional to develop and implement regulatory strategic plans for assigned products. The ideal candidate will have a strong background in regulatory affairs and experience in leading project teams. As a key member of our team, you will be responsible for ensuring quality and timeliness of IND/CTA and BLA submissions. If you are a highly motivated and results-driven individual who is passionate about the pharmaceutical industry, we encourage you to apply for this opportunity.
About the Role
This is an exciting opportunity to join our team and contribute to the development of regulatory strategic plans. As a member of our team, you will have the opportunity to work closely with other functions and partners to prepare, review, and complete documents for regulatory submissions. We offer a competitive salary and benefits package including health insurance, retirement savings plan, and paid time off.
Responsibilities
* Develop and implement regulatory strategic plans in conjunction with project teams
* Own the preparation of major clinical submissions required for regulatory approval
* Work with project teams to resolve complex project issues
* Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure attainment of governmental approvals
* Ensure quality and timeliness of IND/CTA and BLA submissions
Requirements
* Minimum 7 years of pharmaceutical industry experience, at least 6 of which should include regulatory experience
* Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills as evidenced by past performance on drug development project teams
* Ability to coordinate and prioritize assigned projects according to company goals
Benefits
We offer a competitive salary and benefits package including health insurance, retirement savings plan, and paid time off.
We are seeking a highly skilled Regulatory Affairs professional to develop and implement regulatory strategic plans for assigned products. The ideal candidate will have a strong background in regulatory affairs and experience in leading project teams. As a key member of our team, you will be responsible for ensuring quality and timeliness of IND/CTA and BLA submissions. If you are a highly motivated and results-driven individual who is passionate about the pharmaceutical industry, we encourage you to apply for this opportunity.
About the Role
This is an exciting opportunity to join our team and contribute to the development of regulatory strategic plans. As a member of our team, you will have the opportunity to work closely with other functions and partners to prepare, review, and complete documents for regulatory submissions. We offer a competitive salary and benefits package including health insurance, retirement savings plan, and paid time off.
Responsibilities
* Develop and implement regulatory strategic plans in conjunction with project teams
* Own the preparation of major clinical submissions required for regulatory approval
* Work with project teams to resolve complex project issues
* Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure attainment of governmental approvals
* Ensure quality and timeliness of IND/CTA and BLA submissions
Requirements
* Minimum 7 years of pharmaceutical industry experience, at least 6 of which should include regulatory experience
* Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills as evidenced by past performance on drug development project teams
* Ability to coordinate and prioritize assigned projects according to company goals
Benefits
We offer a competitive salary and benefits package including health insurance, retirement savings plan, and paid time off.
