Regulatory Affairs Professional creating clinical evaluation documents for medical devices in a fast - growing biotech company. Collaborating with stakeholders and ensuring compliance with regulations.
About the role
- Senior Director of Regulatory Compliance at Johnson & Johnson, leading compliance strategies for Large Molecule biologics. Involves inspection readiness and collaboration with various departments for compliance assurance.
Responsibilities
- Define and lead a global GMP compliance strategy for Large Molecule biologics that aligns with IM Compliance objectives and business priorities.
- Translate strategy into an annual compliance roadmap with measurable milestones, resource plans and KPIs tied to inspection readiness.
- Oversee compliance across all stages of the biologic’s lifecycle, from production to storage and distribution.
- Ensure that suitable GMP controls are implemented for each type of system.
- Maintain continuous inspection readiness across internal manufacturing sites, CMOs, analytical labs and key suppliers; lead inspection planning, mock inspections, readiness assessments, cross-functional briefings and response coordination.
- Act as primary or co-lead for interactions with health authorities (e.g., US FDA, EMA, MHRA, PMDA), including drafting inspection responses, preparing submission-related GMP evidence and negotiating remediation plans.
- Design and direct a risk-based audit program covering manufacturing sites; oversee audit scope, execution, findings resolution, CAPA effectiveness verification and trending.
- Lead risk identification, assessment and mitigation across biologics manufacturing and support functions; prioritize remediation to reduce patient and regulatory risk while maintaining supply.
- Provide compliance input for regulatory filings, pre-submission meetings and responses to agency questions relative to GMP/CMC readiness and inspection history.
- Build and lead a high-performing Large Molecule compliance team; define competency frameworks and deliver targeted GMP training for manufacturing, analytical and supplier organizations to raise compliance maturity.
- Promote a culture of quality-first decision making, transparent escalation and continuous improvement across the platform.
- Drive continuous improvement initiatives to reduce repeat findings, enhance process robustness and shorten time-to-release while be compliant with regulatory expectations.
Requirements
- Bachelor of Science degree preferred; advanced degree (MS, PhD) desirable.
- Experience providing remediation support for organizations facing FDA Warning Letters or Consent Decrees preferred.
- Background working with agencies such as the US FDA, EMA or MHRA in the context of biologics manufacturing.
- Hands-on operational knowledge of cell banks, upstream cell culture, downstream purification, analytical labs and CMOs for biologics.
- Experience as an Investigator for the US FDA is also acceptable.
- Expertise in biologics modalities, viral clearance/inactivation strategies, potency/assay strategy, stability and comparability assessments.
- Demonstrated success implementing inspection readiness, audit programs and vendor oversight for large molecule products.
- Proven experience collaborating with, or working for, regulatory agencies or health authorities such as the US FDA or MHRA.
- A proven record of leading both direct and indirect teams to accomplish objectives and deliver results.
- Ability to balance technical knowledge of products and processes with a compliance-driven perspective and sound business judgment.
- Candidates must have a minimum of 10 years of experience managing people, including building and developing technical compliance teams.
Benefits
- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays – 13 days per calendar year
- Work, Personal and Family Time – up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
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