European Union Regulatory Affairs, Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs
Achillion is seeking a Director of Global Regulatory Affairs to be based in Blue Bell, PA. Reporting to the SVP Global Regulatory Affairs and Quality & Compliance, this position will be responsible for providing global strategic and operational excellence, leading innovative and ambitious development solutions, and partnering cross-functionally with a sense of urgency, resilience, and energy to meet the unmet medical needs of patients. The incumbent will be the primary point of contact with global regulatory health authorities and will partner with the Quality & Compliance team to ensure compliance and quality in all regulatory communications, submissions, and processes. The incumbent will work closely with the SVP in this highly visible role to build a team and culture that aligns with the values of the organization and focuses on bringing safe, effective, and innovative therapies to patients with unmet medical needs and drive success in executing corporate strategies and goals.
In addition, the incumbent will work closely with teams from Discovery, Clinical Development and Operations, Pharmacovigilance, Medical Affairs, and external consultants to advance the company’s portfolio. The Director of Global Regulatory Affairs will be a strategic, dynamic, highly collaborative and successful leader who brings global regulatory, drug development, orphan and rare diseases experiences and experience in both development and marketed products.
Develop and implement innovative and effective regulatory strategies that may include pursuance of accelerated pathways, Breakthrough designation, Fast Track designation, Priority Review, Orphan designation, and Priority Medicines Scheme (PRIME) designation, in support of bringing Achillion’s portfolio of compounds through development and to the market.
Work in close collaboration with the Senior Vice President of Global Regulatory Affairs and Quality & Compliance, the Regulatory Affairs team members, and consultants/contractors to integrate and successfully implement all aspects of US and global regulatory strategies.
Work collaboratively with cross functional team members and key internal stakeholders to prepare for regulatory submissions including coordination of meeting requests, writing and management of briefing documents, leadership at both rehearsal and meetings/TCs, and appropriate follow-up and integration of results into global strategy
Serve as advisor on regulatory issues in support of portfolio and therapeutic areas; actively collaborate with management and cross functional colleagues within Achillion
Provide expert regulatory affairs review, input, opportunity and risk assessment into confidential, strategic and often complex due diligence initiatives.
Develop, write, and implement standard operating procedures and/or instructions as needed
Provide input into FDA Guidance’s to regulatory policies
Internal: Work with cross functional individuals and teams from Clinical Development, Operations, Pharmacovigilance, Commercial, Legal, Project Management, nonclinical, and Discovery
External: US FDA, EMA, and other global Regulatory Health Authorities; HTAs, and other third-party consultants, contractors, and organizations.
Education and Experience
Bachelor and master’s Degree in a scientific discipline required, Pharm.D., or Ph.D. preferred
10-15 years of global regulatory affairs with proven experience in developing global strategy, operations, and management
Experience providing strategic regulatory advice for the global development of products through all stages of development including pre-approval and marketed compounds.
Prior experience and a successful track record within the biotechnology and pharmaceutical industry in successful submission of INDs, CTAs, Meeting documents, and accelerated pathway designations. Understanding and experience writing and implementing accelerated pathway designations for orphan drugs in the rare disease space
Experience working in a fast-paced, matrixed environment
Technical / Functional Skills and Knowledge
Strong regulatory knowledge of global drug development, including clinical trial requirements, trial design and data analysis, manufacturing, and quality. Strong knowledge of drug development and regulatory policy; excellent scientific and business judgment.
Ability to operationalize strategy and operate effectively within an entrepreneurial and science driven company environment.
Sound project, financial and operational management capabilities; ability to manage expectations, to stay on time and within budgets. Ability to manage complex issues and coordinate multiple projects simultaneously
Ability to build team relationships and collaborate in a global team environment at all levels of the organization. Adept at change management
Strong interpersonal, communication and leadership skills.
Proven track record practicing sound judgment as it relates to risk assessment
Highly conversant and knowledgeable of new and emerging regulations and guidances. Understanding of GMPs, GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information.
Internal Number: RA-2019a
About Achillion Pharmaceuticals
At Achillion, we are driven to transform the lives of patients and families affected by diseases of the complement system, an integral part of the innate immune system. Scientific and clinical evidence has implicated the complement system, and specifically the complement Alternative Pathway(AP), in numerous devastating diseases and conditions. Our principal focus at Achillion is to advance our clinical-stage portfolio of orally administered factor D inhibitors into late-stage development and potential commercialization for patients with devastating disorders of the AP.
Factor D is an essential enzyme upstream in the alternative pathway of the complement system and a target for selective suppression of AP activity. With drug candidates targeting a critical control point for the generation of AP activity, Achillion has prioritized the development of oral factor D inhibitors as potential treatments for patients with C3 glomerulopathy (C3G), a disease affecting the kidneys, and paroxysmal nocturnal hemoglobinuria (PNH), a blood disease. Both conditions are devastating disorders in which overactivity of the AP is recognized as the underlying cause and where there are no approved ther...apies or existing therapies are inadequate for patients.
Our first-generation, oral factor D inhibitor, ACH-4471, has demonstrated initial proof-of-mechanism in both C3G and PNH with clinical development expanded into global, Phase 2 proof-of-concept clinical programs. In addition to ACH-4471, our next-generation oral factor D inhibitors, ACH-5228 and ACH-5548, have advanced into Phase 1 studies. To advance factor D inhibition into late-stage development and potential commercialization, our team plans to partner with key stakeholders including patients and their families, payors, regulators and healthcare professionals.
By combining great science, a growing commercial capability, and a keen understanding of patient needs, Achillion is building an integrated commercial pharmaceutical company capable of bringing oral, factor D inhibition to patients with AP-mediated diseases. Complement focused. Patient driven.