VP, Regulatory Affairs R&D Biopharma

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Vice President, Regulatory Affairs, Biopharma R&D. This position leads the Regulatory Affairs for biopharma R&D, report to the Chief Development Officer for biopharma R&D. Responsible for providing leadership regulatory strategies for earliest possible approvals for the assets under Biopharma R&D.

Focus of Biopharma R&D is Gemtesa, Myfembree, Rethymic and regenerative medicines and CNS assets.

Job Duties and Responsibilities

Regulatory Strategy

• Develop and Manage Regulatory Affairs Strategy
• Develop and gain approval for regulatory strategy to meet the Company’s objectives.
• Oversee the execution of the most effective product registration pathways to bring products to market in a cost-effective and highly compliant manner
• Collaboratively ensure that regulatory strategies are aligned to the SMP group business strategy
• Collaborate with Head of RA at SMP appropriately
• Provide oversight on evaluation and analysis of trends pertaining to government regulatory activities on a global basis and anticipate impacts that changing regulations will have on the Company’s product portfolio.
• Serve as the resident senior expert on all regulatory matters with key external stakeholders, internal steering/review committees, business partners, and government entities on a global basis
• Recommend and facilitate decision making on all Regulatory matters in close partnership with the Chief Development Officer and other key stakeholders
• Establish key business metrics with market reference points to gauge RA productivity and efficiency
• Develop, present and manage RA budget and resource plan in close partnership with regional operating centers, the corporate planning and other appropriate functional groups
• Responsible for providing global guidance and monitoring of global regulatory line items in the clinical development projects budget process
• Serve as the senior point of contact for internal communication
• Ensure that development of launch materials/new claims with Marketing, Medical and Legal are guided by applicable regulatory requirements
• Establish strong education/awareness of regulatory requirements cross functionally through comprehensive education initiatives
• Oversees Regulatory operation and medical writhing team as appropriately
• Perform other duties as directed.

Manage and Develop Talent

• Inspire and lead RA staff to ensure attainment of established goals and objectives
• Ensure global compliance with all relevant internal and external policies and regulations applicable to drug development and regulatory approval
• Promote a high performance –results oriented collaborative work culture
• Establish clear expectations, and monitor delivery of excellent performance
• Establish resource plan to ensure that RA strategy and operational plans are appropriately resourced to support the Company’s business imperatives
• Promote work environment that includes employee development, accountability, proactive feedback and high performance standards

Regulatory Best Practices

• Promote and integrate industry best practices that fit well with the Company’s operating culture
• Promote a highly interconnected RA operating culture
• Establish and oversee compliance to global SOPs and work practices governing all phases of the regulatory process
• Ensure that regulatory pathways are developed to deliver well planned registration roadmap with full understanding of the risks and opportunities
• Develop and manage the regulatory affairs budget with a focus on cost-effectiveness, efficiency and maintenance of quality

Communications

• Accurate and timely reporting status regulatory projects; escalate unresolved issues to appropriate executive leadership
• Steward communications with regulatory agencies to ensure favorable registration outcome

Build and Maintain Key Relationships

• Develop highly collaborative and responsive relationships with key stakeholders
• Represent R&D decision committees defined as company rules

Business Development

• Support Business Development and New Product Planning and assessment activities specifically related to regulatory analysis and due diligence. Also support regulatory filings and joint committee membership with strategic partners

Location and Travel

• Candidate local to the Marlborough, MA is preferred, not required. Primarily remote role with periodic on-site meetings in office.
• Must be able to travel domestically and internationally as needed.

Key Core Competencies

• Highly developed industry and regulatory acumen with the ability to formulate strategies and operational plans that address the interests of the Company
• Highly developed understanding of global regulatory dynamics
• Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values
• Demonstrated ability to align people, policies, and processes to foster a collaborative environment and to sustain collaboration through continual communication of group mission and team based outcomes
• Ability to provide motivational leadership to help the global regulatory organization understand the company’s strategy and future
• Ability to shape and implement and sustain change efforts and instill a culture of accountability and nimbleness
• Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary.
• Requires a high level of initiative and independence.
• Excellent written and oral communication skills required.

Education and Experience

• Doctoral degree (MD, Pharm.D. or Ph.D.) with 20+ of relevant experience in biotech or pharmaceutical industry with at least 10 years of executive management level experience within Regulatory Affairs
• Demonstrated regulatory leadership of early phase to late phase compounds.
• Experience with CBER not only CDER
• Significant international experience working in multicultural and multi-regional environments is required

The base salary range for this role is $280,560 to $350,700. 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.

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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Mental/Physical Requirements: Fast paced environment handling multiple demands. 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.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.