Sumitomo Pharma America, Inc. · 4 days ago
Associate Director, Regulatory Affairs
United States
Full-time
Remote
Director/Executive
$154K/yr - $192K/yr
6+ years exp
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Responsibilities
As a Regional Regulatory Lead, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT)
Ensures execution of regional regulatory plans in line with the global registration strategy in collaboration with the global regulatory leader (GRL)
Leads preparation, coordination, authoring and monitoring of submissions (e.g., IND/NDA submissions, annual reports, investigator brochures, IND amendments, briefing book for FDA meetings) and responses to HA information requests and interacts with Regulatory Operations to submit electronically
Represents GRA on less complex project related meetings and provides regulatory input as appropriate
Assesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines
Leads the documentation of regulatory interactions including decisions and outcomes
Provides updates at the GRT meetings and project teams as needed
Collaborates effectively with Regulatory Operations Leader (ROL)
Maintains professional working relationship with colleagues, fostering collaboration, and idea sharing
Reviews nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contributes to content as needed
Advises team members of major regulatory issues and provides possible solutions, and leads the mitigation strategy
Leads and coordinates local project team members in developing strategy for applicable documents/activities
Ensures quality and content of submissions to Health Authorities
Depending on skill-set and as deemed appropriate by the GRL, may lead regional Health Authority meetings and liaison with local Health Authority and company governance boards for assigned projects
Depending on the skill-set and as deemed appropriate by the GRL, may be the document owner of briefing books to Health Authorities
Assist with development of the global regulatory functional plan through the research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling
Accountable in conjunction with the GRL for developing and maintaining the development core data sheet (DCDS) if required
Depending on the skill-set, ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level
Participates in the promotional materials review committee (PMRC) along with Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of in advertising and promotion
Conducts regulatory review of promotional and non-promotional materials in accordance with business goals and objectives, Health Authority regulations, ICH guidelines, PhRMA guidelines, company policies and established precedents and recommends revisions/actions that balance risks and opportunities
In collaboration with the Regulatory Operations Leader (ROL), ensures all submissions to the Office of Prescription Drug Promotion (OPDP) are complete and presented to facilitate agency review
Qualification
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Required
Master’s degree required (preferably in a scientific discipline)
6 – 8 years relevant experience in biotech or pharmaceutical industry with minimum of 6 years focused in Regulatory Affairs
Strong verbal and written communication, interpersonal, listening, and organizational skills required
Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values
Ability to work in a diverse environment
Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization
Demonstrated ability to facilitate appropriate team decisions
Sense of urgency and perseverance to achieve results
Experience contributing to electronic regulatory submissions and working with regulatory templates
Solid understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical industry
Experience reviewing nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, Investigator Brochures, CMC information/data) and contribute to content as needed
Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution
Capable of effectively negotiating with others while maintaining composure
Experience interacting with the FDA
Experience in successfully leading teams
Develop and prepare successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document in coordination with clinical plans and marketing objectives
Proven success/major involvement in major submissions and approval
Ability to learn new therapeutic areas when necessary
Expertise on regulations governing promotion and advertising of assigned products.
Preferred
Doctorate preferred (Pharm.D., Ph.D., M.D., etc.)
Prior history with post-marketing/brand optimization strategies and commercial awareness
Benefits
Merit-based salary increases
Short incentive plan participation
Eligibility for our 401(k) plan
Medical, dental, vision, life and disability insurances
Unlimited paid time off
11 paid holidays plus additional time off for a shut-down period during the last week of December
80 hours of paid sick time upon hire and each year thereafter
Company
Sumitomo Pharma America, Inc.
Sumitomo Pharma America (SMPA) is a science-based, technology-driven biopharmaceutical company focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need in psychiatry and neurology, oncology, urology, women’s health, rare disease, and cell and gene therapies.
1,001-5,000 employees
H1B Sponsorship
Sumitomo Pharma America, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (5)
Funding
Current Stage
Late StageLeadership Team
Adele Gulfo
Chief Executive Officer, Biopharma Commercial
Myrtle Potter
President and Chief Executive Officer, Sumitomo Pharma America
Company data provided by crunchbase
