Head of International Regulatory Affairs - Apraglutide

at  Ironwood Pharmaceuticals

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).

POSITION DESCRIPTION:

The Head of International Regulatory Affairs, Apraglutide (also referred to as the Head of International), 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 EU and international regulations. The Head of International 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 Head of International is effective in collaborating cross-functionally and provides leadership by communicating, executing, and providing expert guidance to team members on regional regulatory requirements and policies to achieve the department/corporate objectives. This individual gathers data and required documents for domestic and international submission purposes, develops regulatory strategies for new products or changes to existing products, maintains existing registrations, and supports change management. The Head of International will work with the cross-functional team to combine knowledge of scientific, clinical, regulatory, and business to lead and support the development of products that meet the regulatory requirements in the intended markets. This individual will also lead discussions and negotiations with regulatory bodies. The Head of International will have direct reports that require mentoring and development.
The Head of International for apraglutide is responsible for leading the upcoming MAA submission and for supporting partner submissions in multiple jurisdictions. Apraglutide is a next-generation, long-acting synthetic GLP-2 analog developed for a range of rare gastrointestinal diseases where GLP-2 can play a central role in addressing disease pathophysiology, including short bowel syndrome with intestinal failure (SBS-IF).
This role is located in Basel, Switzerland (remote) with occasional travel to Boston, USA. This role reports to the Head Global Regulatory Affairs, Apraglutide.

Requirements:

• Master’s degree in a science field such as Biology, Chemistry, or Pharmaceutical sciences;
• At least 15+ years of pharmaceutical industry experience inclusive of 10 years of global Regulatory Affairs experience or a combination of 8+ years of global Regulatory Affairs and related experience;
• Demonstrated recent successful 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 international countries. Rare disease and pediatric drug development experience is highly desirable;
• Strong working knowledge regarding the selection, development, and evaluation of Clinical Outcome Assessments (COAs);
• Candidates must have proven strategic development capabilities related to new drug development, commercial support, partner management, as well as product lifecycle management activities (including relevant interactions with international Business Partners/CROs);
• An extensive background and excellent relationship in working with the EU EMA and/or other regulatory agencies; broad experience in global drug development;
• Regulatory strategic and operational support to implement global Managed Access Programs;
• Strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner, particularly in relation to regulatory strategies;
• Strong oral and written communication, time management, and team-oriented leadership skills are essential;
• Ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors

• 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;
• Participate in or lead departmental and cross-functional task forces and initiatives;
• Demonstrate ability to anticipate risks and be responsible for developing solutions to identified risks; understand probabilities of technical success for the solutions;
• 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;
• Understand and interpret scientific data as it relates to regulatory requirements and strategy for assigned projects and provide knowledge and expertise to guide the team in established and building appropriate regulatory strategy;
• Demonstrate a solid understanding of current 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.
• Demonstrate increasing independence in the area of regulatory strategy, such as understanding broad concepts within Regulatory Affairs and implications across the organization and globally; proactively identify regulatory issues; offer creative solutions and strategies, including risk mitigation strategies;
• Provide strategic and tactical advice to internal teams to achieve timely and efficient development and maintenance of programs while ensuring compliance with applicable regulatory requirements;
• Closely collaborates with external partners and stakeholders to ensure alignment with the partner and seamless execution of endorsed regulatory strategies
• Direct the preparation of CTAs, amendments, briefing documents, and marketing applications
• Point-lead for interfacing with Health Authority review teams and is a leader that facilitates approval of regulatory submissions and coordinates responses to Health Authorities with appropriate personnel and departments to resolve new or outstanding regulatory issues;
• Represent 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;
• Communicate with internal and external stakeholders, including members of the leadership teams, to ensure cross-functional alignment, Work with Medical Writing, CMC and Regulatory Operations teams to establish and meet timelines for regulatory submissions;
• Regularly report to management on progress against objectives and plans. Plan and direct projects and provide technical background, inspiration, leadership, and consultation to cross-functional colleagues as well as members of the global regulatory project team;
• Provides regulatory input to patient-centered outcomes research, market access/HTA strategy and submissions;
• Monitors and shares Regulatory Intelligence;
• Directly managers the team of regulatory affairs experts
• Oversees functional budget;

• Other Regulatory Affairs duties as assigned or as business needs require.

  Requirements:

• Master’s degree in a science field such as Biology, Chemistry, or Pharmaceutical sciences;

• At least 15+ years of pharmaceutical industry experience inclusive of 10 years of global Regulatory Affairs experience or a combination of 8+ years of global Regulatory Affairs and related experience;
• Demonstrated recent successful 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 international countries. Rare disease and pediatric drug development experience is highly desirable;
• Strong working knowledge regarding the selection, development, and evaluation of Clinical Outcome Assessments (COAs);
• Candidates must have proven strategic development capabilities related to new drug development, commercial support, partner management, as well as product lifecycle management activities (including relevant interactions with international Business Partners/CROs);
• An extensive background and excellent relationship in working with the EU EMA and/or other regulatory agencies; broad experience in global drug development;
• Regulatory strategic and operational support to implement global Managed Access Programs;
• Strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner, particularly in relation to regulatory strategies;
• Strong oral and written communication, time management, and team-oriented leadership skills are essential;
• Ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors.