Regulatory Lead

Hiring Manager: SVP, Regulatory Affairs and Drug Development
Date Opened: May 2019

Position Summary:

The Regulatory Lead will be responsible for developing, driving, and implementing (through internal interactions and working with consultants/partners) global regulatory strategies for small molecules and biologics across multiple indications. This individual will be a core member of the program teams and support regulatory strategies necessary to evaluate clinical options, enable plans, and optimize development programs. Additionally, this individual will have an understanding of relevant development and scientific issues and take a data-driven approach to drug regulatory affairs.

Roles & Responsibilities:

  • In collaboration with the SVP Regulatory Affairs and Drug Development, and the ED Regulatory Affairs, design, implement, drive, and monitor global Regulatory strategies to inform Boston Pharmaceuticals’ programs.

  • Liaise with internal teams and external partners in order to execute program team objectives. This includes the evaluation of regulatory risks/gaps and developing contingency plans with a focus on efficient global planning for first in human and proof of concept (POC) studies.

Qualifications:

  • Bachelors or higher in pharmaceutical sciences or related field required

  • Experience (5-10 years) in the biopharma industry in a Regulatory Affairs role and proven ability to represent Regulatory Affairs on project teams and to Health Authorities

  • Demonstrated leadership of regulatory submissions, including effective project management.

  • Must have experience in drug development, particularly in late preclinical stage and in phase 1 and 2 clinical trials

  • Excellent communication and organizational skills

  • Strong attention to detail and process oriented

  • Strong time management skills; ability to prioritize multiple tasks efficiently 

  • Resourceful and flexible: manage multiple and changing priorities in a dynamic environment

  • Ability to think creatively and independently, and to proactively manage regulatory risk

  • Ability to collaborate with teams to achieve goals and objectives.

  • Track record of providing scientifically informed regulatory advice which includes strategic options and associated risks.

  • Strong team player: demonstrated ability and willingness to work on a team, assist team members as needed and accomplish tasks required to achieve goals.