Dir, Regulatory Strategy

Benefits

Parental leave

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Non-birth-parent leave

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Family-building benefits

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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

Not verified last checked Jun 13, 2026

Salary

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401(k) match

Listed Source: EMPLR_CONTRIB_INCOME_AMT. source Last checked Jun 13, 2026.

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Schedule

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Weekend work

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Application

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Deadline

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Where they hire

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About this role

Dir, Regulatory Strategy Waltham, MA, United States We are seeking an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As a Director of Regulatory Affairs, the successful candidate will play an important role in guiding new products into the clinic and setting the stage for registration. The individual in this role will serve as a Regulatory Lead for pipeline drug development programs and marketed products, and will be responsible for developing, implementing, and driving global Regulatory strategies. The ideal candidate will have a strong scientific background, broad experience developing drugs, and the ability to leverage that experience to impact program teams beyond regulatory strategy. This role reports to the Sr Director, Regulatory Affairs (Strategy) Serve as Regulatory Lead, representing the Global Regulatory Team on cross-functional development teams Develop and implement global regulatory strategies for pipeline drug development programs and marketed products Identify innovative, data-driven regulatory approaches, define plans to proactively mitigate risks, and monitor the competitive and policy landscape for changes with potential impact Lead the organization and preparation of clear and effective regulatory submissions that align with company strategies and Health Authority requirements Foster strong relationships with relevant regulatory agencies and key stakeholders while advocating for company positions Lead interactions with Health Authorities, interpret feedback, and ensure that the outcome is properly communicated to the Organization. Create a strong regulatory community and share best practices across the broader Regulatory Affairs organization Effectively represent the Regulatory Affairs function to senior leadership at governance

Read the full description at hbap.fa.us1.oraclecloud.com. FewerJobs shows a source-linked preview and links to the original posting.