Director, Global Regulatory Affairs
vor 3 Wochen
VectivBio is a global, clinical-stage biotechnology company focused on the discovery, development, and commercialization of innovative treatments for severe rare conditions with high unmet medical need. VectivBio is now a part of Ironwood Pharmaceuticals, Inc., a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, and has operations in Basel, Switzerland.
The Company’s lead product candidate, apraglutide, is a next-generation, best-in-class, synthetic peptide analog of glucagon-like peptide-2, or GLP-2, is in Phase 3 to treat patients with short bowel syndrome, or SBS, a malabsorption disorder caused by the loss of functional small intestine. Apraglutide is also in Phase 2 for the treatment of acute graft-versus-host disease (GVHD).
Purpose of this role:
The Director, GRA will report to the Head of GRA, Apraglutide, and will be responsible for providing company-wide regulatory direction for product development and guidance to develop rapid successful strategies for market approval(s) aligned with business objective(s) and compliance with applicable European, US and international regulations. The Director, GRA will develop and advance organizational policies and procedures, while also anticipating regulatory obstacles and risks/emerging issues that may impact current or future projects while developing the corresponding solutions. The Director will be effective in collaborating within the organization and provide leadership by communicating, executing, and providing guidance to team members toward achieving the department/corporate objectives.
Organizational Home:
This role is located in Basel, Switzerland (remote) with occasional travel to Boston, USA.
Major Accountabilities:
Develop/lead/implement regulatory strategy through a global regulatory team approach for assigned projects or product(s) across all phases of product development, and ensure timely development of regulatory strategy and operating plans; In close collaboration with the Head of GRA, Apraglutide, leads the design and implementation of core submission team meetings and plans to ensure clear status and adherence to schedule, with timely escalation as required. Coordinates, supports and ensures alignment in regard to Partner submissions to ensure clear status of the activities and adherence to the agreed schedule. Ensures timely escalation of issues and concerns with impact assessment and risk mitigation plans as required. In close cross-functional collaboration prepares INDs, CTAs, amendments, briefing documents, and marketing applications (NDAs, MAAs) as needed; Demonstrates a solid understanding of current US and EU regulations and guidance, political and legal climate, and industry practices to assist in meeting organizational goals. Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas. Anticipates risks and proactively develops solutions to identified risks; understands probabilities of technical success for the solutions; Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide the team in building appropriate regulatory strategy; Demonstrates independence in the area of regulatory strategy such as understanding broad concepts within Regulatory Affairs and implications across the organization and globally; Represents company at regulatory agencies for assigned products, including planning and conducting meetings, as well as ensuring submitted documents are compliant and of the highest quality; Monitors and shares Regulatory Intelligence; Works with cross-functional teams and GRA team members to ensure adherence to timelines for regulatory submissions. Regularly reports to line management on progress against objectives and plans. Directs project execution against plan and provides technical support, inspiration, leadership, and consultation to cross-functional colleagues as well as members of the global regulatory project team. Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgment and communicating in a professional and timely manner; Other regulatory affairs duties as assigned or as business needs require.Profile (Skills, experiences, and qualifications required for the job)
Bachelor’s degree in a science field such as Biology, Chemistry, or Pharmaceutical sciences. Advanced degree preferred, but not required. At least 8+ years of Regulatory Affairs experience in small molecule or biologic drug development and registration activities or a combination of 6+ years of Global Regulatory Affairs and related experience. Candidates must have proven strategic development capabilities related to new drug development and commercial support activities. Demonstrated recent successful global Regulatory Affairs track record in the development, submission, and registration of new drugs (biologics, innovative medicines, drug/device combination products, etc.) in the EU and internationally. Rare disease and pediatric drug development experience is highly desirable. Must have strong communication and interpersonal skills needed to influence internal stakeholders in a diplomatic manner to ensure project success. Demonstrate excellent teamwork and communication skills with the ability to impact and influence the decisions of a team. Good oral and written communication, time management, and team-oriented leadership skills are essential. Excellent computer and project management skills are essential for the successful candidate.-
Director, Global Regulatory Affairs
vor 3 Wochen
Basel, Schweiz Ironwood Pharmaceuticals VollzeitVectivBio is a global, clinical-stage biotechnology company focused on the discovery, development, and commercialization of innovative treatments for severe rare conditions with high unmet medical need. VectivBio is now a part of Ironwood Pharmaceuticals, Inc., a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of...
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