Scope: The Vice-President, Regulatory Affairs in partnership with the CMO and other key stakeholders will develop, operationalize and steward the Company’s global regulatory strategy and operational plans covering the full life cycle of registration and post marketing pathway for all pipeline products and commercial stage assets. The incumbent will build a high performing and collaborative RA team and serve as a player coach leader to advance the Company’s assets through the various regulatory stages.
Specific Job Duties:
Develop regulatory strategies for individual programs including all preparatory planning for successful registration in markets assigned to the company
Develop and assess optimal routes to approval and lead communication and negotiation activities with applicable regulatory agencies to pave way for successful submissions for all early, clinical and commercial stage pipeline assets.
Directly or through the RA colleagues provide strategic regulatory leadership for all early stage and clinical development projects and conduct regulatory risk assessments and mitigation for all Company programs
Prepare briefing and regulatory documents for regulatory agencies, such as Dossiers, NDAs, INDs, and Annual reports. Respond to regulatory agencies with intelligence, diplomacy and a tone that conveys collaboration and partnership
Ensure that all domain/functional teams spanning the life cycle needs of each asset are appropriately informed and are appropriately structured to meet applicable domestic and international regulatory requirements in geographies of interest to the Company.
Build productive and respectful partnerships with key stakeholders from other functions within the parent-subsidiary operating environment and external partners to ensure that the Company’s strategic business imperative are met through sharing of knowledge, expertise, and relevant information
Provide guidance and information to the Company’s executive and R&D management on emerging trends, regulations, and health authority guidelines to ensure use of the desired regulatory strategies
Provide counsel, training and interpretation of FDA and other regulatory requirements to research and development teams and other appropriate personnel. Cultivate an atmosphere of transparency and problem-solving that encourages requests for advice and input by employees
Proactively interpret and communicate regulatory expectations to internal and external stakeholders (including partners, CROs, CMOs, consultants, and contractors) in order to execute program objectives in full compliance with applicable regulations
Develop and maintain strong relationships with key internal and external stakeholders including regulatory officials
Work collaboratively with domain/functional leaders to support operational compliance to all applicable policies and standards governed by prevailing regulatory agencies
Represent and provide Regulatory Affairs expertise to the Company’s Promotional Review Committee regarding advertising and promotional materials
Work in a highly collaborative manner with cross-functional teams within affiliates and parent company
Perform other duties as assigned by the Company
PhD in a scientific area and at least fifteen (15) years of progressively responsible experience in regulatory affairs within the biopharmaceutical industry, or equivalent. Must have at least ten (10) years of experience in a management role developing a high performing regulatory team
Experience with regulatory aspects of oncology or rare disease products
Ability to apply knowledge of FDA , EMA, and ICH guidelines both strategically and operationally
Experience leading regulatory aspects of early and late stage drug development through market launch
Regulatory experience with diagnostics a plus
Demonstrated experience and expertise in preparing complex regulatory documents including INDs, milestone briefing packages (EOP2, EOP3, pre-NDA, Scientific Advice), NDAs, and other major regulatory submissions
Must have extensive knowledge of the regulations, regulatory process and requirements in all major global markets
Ability to influence direction of complex regulatory issues; solicits information, listens well, persuades others to make important decisions and shape outcomes
Demonstrated grace and even temperament under pressure
Proven leader with a strong results orientation, positive “hands on” attitude and a sense of urgency to get things done
Strong analytical, written and oral communication skills
Ability to travel up to 20% [domestic and international]
Employer will assist with relocation costs.
Additional Salary Information: Offering a competitive salary package, inclusive of short and long-term bonus.
Internal Number: 1
About Boston Biomedical Inc.
Boston Biomedical, Inc. is a leading developer of novel cancer therapeutics with the goal of significantly improving patient outcomes. We have a range of expertise including advancing the research and development of multiple compounds and clinical programs.
Founded in 2006, Boston Biomedical is headquartered in Cambridge, Massachusetts, one of the world’s most prominent hubs for life science innovation. Our company is wholly owned by Sumitomo Dainippon Pharma Co. Ltd., a leading global pharmaceutical company based in Japan.
With the support of our parent company, Sumitomo Dainippon Pharma Co., Ltd., we work closely together with Tolero Pharmaceuticals and Sumitomo Dainippon Pharma’s Cancer Institute, to rapidly advance a pipeline of innovative treatments for patients with cancer. In addition, through our External Innovation efforts, we are expanding our research partnerships to advance the discovery of novel therapeutics.
We believe that our innovative business approach will expedite the drug discovery, development, and commercialization process and provide the potential to bring treatments to patients that provide a meaningful difference in their lives.