Senior Associate, Regulatory Affairs

Responsibilities:

• Assist Regulatory Lead to support local regulatory activities (e.g., IND/CTA submissions and agency meetings).
• Provide and maintain IND/CTA documentation support in collaboration with Regulatory Lead (e.g., draft and prepare forms and cover letters, liaise with and transfer documents for submissions to/from the publishing vendor or CRO).
• Create and maintain product regulatory information and history documents (e.g., maintain correspondence logs).

• Appropriately archive regulatory documents and agency communications.

• Collaborate with CRO’s / partners to support clinical study activities.
• Complete regulatory forms to support agency communications.
• Provide regulatory support through cross-functional interactions in project meetings.
• Support the development and execution of project goals.
• Monitor the development of new regulatory requirements or guidance documents and support Regulatory Lead to advise product teams of the impact on the business or development programs.
• Has flexibility to react rapidly to changing situations/environment.
• Willing to travel for occasional in-person team meetings.

Qualifications:

• A Bachelor’s degree in a scientific discipline is required. A relevant advanced degree (e.g., MS, PharmD) is preferred and certification is a plus.
• Minimum of 2 years in the pharmaceutical industry.
• Strong interpersonal, written, and verbal skills.
• Ability to understand and communicate scientific/clinical information.
• Ability to collaborate with team members to tackle problems and develop a course of action.
• Strong planning and organizing skills.
• Ability to prioritize and balance multiple activities.
• Ability to deal with ambiguity and fast-paced environment.

Location: This is a hybrid position with three days per week onsite at our office in Burlington, MA or Redwood City, CA.

MapLight is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.