Director, Regulatory Affairs

Job Overview:

This position reports to Executive Director, Regulatory Affairs and is part of the Biopharma R&D Regulatory Affairs organization based in the US. The role is responsible for serving as the Global Regulatory Leader (GRL) and/or Regional Regulatory Leader (RRL) for assigned projects and works closely with cross-functional teams to ensure effective collaboration and alignment.

This position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval for projects within the CNS portfolio of the company. This position may train/mentor junior staff.

This position works with a high level of autonomy and requires limited coaching and mentoring.

Essential Functions Required for Job:

• Leads the Global Regulatory Team (GRT) and regulatory activities for assigned project(s) in line with the global registration strategy of the product
• As a Regional Regulatory Lead, if applicable, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT)
• Competently represents RA on project team meetings
• Leads and coordinates project team members in developing regulatory strategy for applicable documents/ activities.
• Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations on electronic submissions
• 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. summary documents, 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, if applicable, for developing and maintaining the development core data sheet (DCDS) and company core data sheet (CCDS) 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.

Knowledge, Skills and Abilities (general & technical):

• Strong verbal and written communication skills; interpersonal skills; listening skills; organizational skills; and attention to detail 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 pre-IND/IND/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
• Experience in CNS development and ability to learn new therapeutic areas when necessary
• Prior history with post-marketing/brand optimization strategies and commercial awareness
• 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.

Education & Experience Requirements:

• Bachelor's degree in a related field required.
• Minimum 10 years of relevant experience in biotech or pharmaceutical industry
• Master's degree required (preferably in a scientific discipline)

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

People Management:

This is an individual contributor role and does not have direct reports or formal people-management responsibilities.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

The base salary range for this role is

$195,900.00 - $244,900.00

Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible 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. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.