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MapLight Therapeutics, Inc. · 2 days ago

Sr. Associate, Regulatory Affairs

Burlington, MA

Full-time

Hybrid

Entry, Mid Level

$87K/yr - $114K/yr

2+ years exp

MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. The role involves supporting local regulatory activities, maintaining documentation for IND/CTA submissions, and collaborating with partners to facilitate clinical study activities.

BiopharmaBiotechnologyLife ScienceMedical

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

Qualification

Regulatory AffairsPharmaceutical Industry ExperienceScientific CommunicationProject ManagementVerbal SkillsPlanningOrganizingInterpersonal SkillsWritten SkillsProblem SolvingAdaptability

Required

A Bachelor's degree in a scientific discipline is required

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

Preferred

A relevant advanced degree (e.g., MS, PharmD) is preferred and certification is a plus

Benefits

Annual bonus opportunity

Medical

Dental

Vision

Life and AD&D

Short term and long term disability

401(K) plan with match

Stock options

Flexible non-accrual paid time off

Parental leave

Company

MapLight Therapeutics, Inc.

Maplight is a biopharmaceutical company discovering and developing novel therapeutics for patients with disorders of the central nervous system (CNS).

Founded in 2018

Palo Alto, California, USA

51-200 employees