Sumitomo Pharma America, Inc. · 4 hours ago
Director, Regulatory Affairs
United States
Full-time
Remote
Director/Executive
$183K/yr - $229K/yr
8+ years exp
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Responsibilities
Manage and Develop Talent
May train/mentor junior staff
Phases I-IV Research & Development Activities
As a Regional Regulatory Lead, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT)
As a part of the Global Regulatory Team (GRT), leads regulatory activities for assigned project(s) in line with the global registration strategy of the product
Competently represents GRA on project team meetings
Leads and coordinates project team members in developing strategy for applicable documents/ activities.
Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission
Assesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines
Leads documentation of regulatory authority interactions including decisions and outcomes
Provides updates at the Global Regulatory Team 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 the quality and content of all submissions to Health Authorities
Leads the regional health authority meetings, liaison with local Health Authority
Document owner of briefing book documentation to Health Authorities
Assist with development of the global regulatory functional plan through 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
Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level
Provide strategic review of dossier summaries, expert statements, and development management plans
Provide updates to the GRT, project teams, and governance boards as needed
Leads Global Regulatory Team (GRT), oversees planning and execution of global regulatory activities and submissions
May be responsible for creating and reviewing SOPs and regulatory department operating procedures.
Qualification
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Required
8 – 12 years with Master’s of relevant experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory affairs.
Master’s degree required (preferably in a scientific discipline).
Strong verbal and written communication skills; interpersonal skills; listening skills; 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.
Advanced 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.
Proven success/major involvement in NDA/MAA/CTD submissions and approval.
Capable of effectively negotiating with others while maintaining composure.
Development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document.
Ability to learn new therapeutic areas when necessary.
Prior history with post-marketing/brand optimization strategies and commercial awareness.
Expertise on regulations governing promotion and advertising of assigned products.
Experience interacting with the FDA and ex-US Health Authorities.
Experience in successfully leading teams and providing leadership in Health Authority negotiations and meetings.
Ability to make complex decisions and willingness to defend difficult positions.
Comfortable presenting to all levels of the organization including Senior Management.
High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture.
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
