Director, Regulatory Affairs

Sumitomo Pharma•Marlborough, MA

9d•Remote

About The Position

Sumitomo Pharma America, Inc. (SMPA) is seeking a Director, Regulatory Affairs to join its Biopharma R&D Regulatory Affairs organization in the US. This role reports to the Executive Director, Regulatory Affairs and serves as the Global Regulatory Leader (GRL) and/or Regional Regulatory Leader (RRL) for assigned projects. The position is responsible for leading the development and implementation of regulatory strategy from proof of concept through post-approval for projects within the CNS portfolio. The role requires a high level of autonomy and limited coaching. This position may also train or mentor junior staff.

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).
Strong verbal and written communication skills; interpersonal skills; listening skills; organizational skills; and attention to detail.
Unquestionable ethics, professional integrity, and personal values consistent with SMPA values.
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 and contributing 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 interdependencies and the big picture.
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.

Nice To Haves

Experience in CNS development and ability to learn new therapeutic areas when necessary.
Prior history with post-marketing/brand optimization strategies and commercial awareness.

Responsibilities

Leads the Global Regulatory Team (GRT) and regulatory activities for assigned project(s) in line with the global registration strategy of the product.
Manages regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT), if applicable.
Represents Regulatory Affairs (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, working closely with Regulatory Operations on electronic submissions.
Assesses and communicates regulatory requirements, ensuring activities comply with applicable regulations and guidelines.
Leads documentation of regulatory authority interactions, including decisions and outcomes.
Provides updates at Global Regulatory Team meetings and project teams as needed.
Collaborates effectively with the regulatory operations leader (ROL).
Reviews nonclinical, clinical, and CMC documentation and contributes to content as needed.
Advises team members of major regulatory issues, provides possible solutions, and leads the mitigation strategy.
Ensures the quality and content of all submissions to Health Authorities.
Leads regional health authority meetings and liaises with local Health Authorities.
Serves as the document owner of briefing book documentation to Health Authorities.
Assists with the 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.
Is accountable, in conjunction with the GRL, for developing and maintaining the development core data sheet (DCDS) and company core data sheet (CCDS), if required.
Ensures compliance with global regulatory requirements and adherence to internal policies and processes, coordinating regulatory compliance activities globally.
Provides strategic review of dossier summaries, expert statements, and development management plans.
Oversees planning and execution of global regulatory activities and submissions.
May be responsible for creating and reviewing SOPs and regulatory department operating procedures.