Medical Director
LifeMD
VP, Regulatory Affairs – R&D, Biopharma
Sumitomo Pharma America, Inc.
full-time
Posted on:
Origin: • 🇺🇸 United States • Massachusetts
Visit company websiteSalary
💰 $280,560 - $350,700 per year
Job Level
Lead
About the role
- 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.
- 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.
Requirements
- 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
- Highly developed industry and regulatory acumen with the ability to formulate strategies and operational plans
- Highly developed understanding of global regulatory dynamics
- Unquestionable ethics, professional integrity, and personal values
- Ability to align people, policies, and processes to foster collaboration
- Motivational leadership skills to guide global regulatory organization
- Ability to shape and implement change and instill accountability
- Fast paced environment handling multiple demands
- Excellent written and oral communication skills
