Senior Associate, Regulatory Affairs

Benefits

Parental leave

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Non-birth-parent leave

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Family-building benefits

• Fertility benefits: Not verified
• Adoption assistance: Not verified
• Surrogacy assistance: Not verified

Mental health support

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Relocation assistance

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Childcare support

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Learning budget

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Verification

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Salary

$87K-$114K not verified - timestamp not recorded

401(k) match

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Market context

U.S. role benchmark (BLS OEWS)

$61,842 U.S. median for this role

Projected growth (BLS Employment Projections)

+1.9% - Slower

63% above the BLS role benchmark for operations aggregate.

Matched to SOC 11-1021 - Operations aggregate by role bucket.

Source: U.S. Bureau of Labor Statistics, OEWS, May 2024 and Employment Projections, 2024-2034.

Schedule

Shift type

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Weekend work

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Application

Cover letter

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Assessment

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Deadline

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Where they hire

State eligibility is not yet verified.

About this role

Senior Associate, Regulatory Affairs Burlington, MA Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms. 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

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