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Regulatory Manager

3 months ago

Brockton, Massachusetts, United States Mindlance Full time

Job Title: Regulatory Affairs Specialist Project Lead I

Location: REMOTE

Duration: 06 months with possible extension

SUMMARY

Fully Remote, open to candidates in all US time zones.

However, must be able to work M-F 8 AM - 5 PM ET time zone.

Possibility for an extension

Top 3 Must Have:


• Leadership capabilities and ability to work with cross-functional team


• Knowing when to escalate concerns


• Regulatory Experience, 5 years of relevant Regulatory Affairs experience (regionally and/or global), in early development

Top Nice Skills:


• Advanced Degree


• Filed marketing application (strong plus before)

This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS) for immunology products in Early Development.

Additionally, this role leads the development of a global HA (Health Authority) interaction plan and strategy in collaboration with GRT (Global Regulatory Team) and is accountable for the communication of the key outcomes to senior management.

Education and Experience:


• BS/BA degree in a relevant scientific discipline required. Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) is preferred.


• At least 8-10 years of relevant pharmaceutical/biotechnology experience in R&D, including at least 5 years of relevant Regulatory Affairs experience (regionally and/or global), in early development.