Regulatory Affairs Associate for managing new drug registrations and preparing documentation in the India Market. Collaborating with stakeholders and supporting compliance in bulk drug registration.
About the role
- Director leading global regulatory strategy for biomarkers and diagnostics in early-stage development with Bristol Myers Squibb. Focus on regulatory submissions and patient stratification in clinical studies.
Responsibilities
- Lead global regulatory strategy for biomarkers and diagnostics.
- Focus on early-stage development through proof of concept and supporting registrations.
- Establish scalable frameworks for investigational assay development, ensuring timely, compliant submissions that support patient stratification in Phase I/II studies.
- Serve as the regulatory lead on the Translational Medicine CLIA Laboratory Steering Committee.
- Champion innovative regulatory strategies to resolve complex challenges and accelerate patient access.
- Cultivate inclusive, high-impact collaboration with Precision Medicine, Research teams, Global and Regional Regulatory Leads, Global Regulatory Operations, and Quality.
- Oversee global precision medicine submissions and health authority interactions including PSAs, SRD, Pre-subs, IDEs, and international submissions.
- Provide regulatory support on product partnership, vendor management, and business development opportunities.
- Act as a strategic regulatory thought leader by shaping policy through trade association engagement and maintaining awareness of scientific, competitive, and diagnostic industry trends.
Requirements
- Solid scientific background, PhD., M.D., PharmD, MS
- Significant experience in regulatory affairs and diagnostic-related development e.g., >8-10 years.
- Deep expertise in global diagnostic development—including, but not limited to key markets such as US, EU, Canada, Australia, Japan, China submissions, etc.—with preferred subject matter proficiency in IHC, NGS, PCR, and/or mass spectrometry, spanning assay design through regulatory approval.
- Extensive experience in designing regulatory strategies for companion diagnostics and biomarkers, with deep expertise in assay and IVD development—including analytical validation, clinical development, manufacturing, and global regulatory submissions through commercialization.
- Proven ability to lead teams through complex health authority interactions and issue resolution, paired with deep expertise in developing and executing global regulatory strategies across drug and device development.
- Mastery of regulatory standards, but not limited to GCP, GLP, CLIA, HIPAA, 21 CFR Parts 11, 312, 812, 820, ISO 13485, ISO 14971, EU IVDR, CMDR, TGA, PMDA, NMPA, and ICH guidelines to ensure compliance and quality across investigational use only assay programs.
- Skilled in translating complex scientific and regulatory concepts into clear, actionable insights for senior leadership and cross-functional teams.
- Builds strong partnerships across internal and external stakeholders in matrixed environments to drive alignment and shared success.
- Demonstrates high personal accountability and excels in facilitation, negotiation, and strategic influence.
- Values diverse perspectives, fosters a culture of continuous improvement, and encourages open dialogue on risks, issues, and successes.
Benefits
- Medical, pharmacy, dental and vision care.
- Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
- Financial well-being resources and a 401(K).
- Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
- Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
- Parental, caregiver, bereavement, and military leave.
- Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
- Other perks like tuition reimbursement and a recognition program.
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