Achillion Pharmaceuticals is seeking a Director of Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) to join our growing team in the Blue Bell, Pennsylvania office. Reporting to the Head of Global Regulatory Affairs, the incumbent will have a critical role in the department with responsibility for all CMC-related strategy, development, and oversight supporting the corporate objectives. The incumbent will partner closely with senior leadership in Pharmaceutical Science, Global Regulatory Affairs, Quality & Compliance, and other key functional areas, as well as external partners and Contract Manufacturing Organizations (CMO), to drive successful global regulatory development and registration strategies for all Achillion assets.
The Director of Regulatory Affairs CMC will work closely within a team and be responsible for assuring compliance with Good Manufacturing Practices (GMPs), drafting, authoring, reviewing, and submitting key regulatory documents including Investigational Medicinal Product Dossier (IMPD), CMC sections of Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Clinical Trial Applications (CTAs), Marketing Authorization Applications (MAAs), and other documents as needed. The incumbent will also represent Achillion at global health authority meetings where CMC matters/topics are being discussed including those with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and others as required. The incumbent will also have responsibility for working with both internal and external stakeholders to ensure inspection readiness and preparedness at both Achillion and CMO facilities.
Develop and support the global regulatory CMC strategy in partnership with the Pharmaceutical Science team to support all Achillion clinical studies and meet corporate objectives
Integrate into the ongoing technology transfer team to provide regulatory leadership and strategy supporting corporate decisions and manufacturing goals
Develop and write all CMC regulatory documents supporting global submissions
Be the company representative for regulatory CMC at health authority meetings and interactions
Provide leadership, support, and resource to the Pharmaceutical Science team in preparing and finalizing all necessary manufacturing documents in support of IND, NDA, MAA, and other critical applications
Partner with the global Regulatory Affairs and Quality & Compliance teams to provide regulatory CMC support, leadership, and resource to ensure inspection readiness and preparedness
Bachelor of Science degree in a physical science, Masters or other advanced degree preferred
Minimum of 10 years experience working in a regulatory CMC function with direct responsibility for leading regulatory strategy, writing key documents including IMPD, IND, NDA, and attending regulatory meetings with health authorities including the FDA and the EMA
Demonstrated experience partnering with Pharmaceutical Science personnel and other functions to support, address, and/or solve critical challenges facing the regulatory CMC function
Experience working and leading in a matrix environment
Experience working in both large pharmaceutical and small biotechnology organizations
Previous experience and responsibility supporting technology transfer of small molecule active pharmaceutical ingredient and drug product from one CMO to another
Experience participating in an inspection by FDA and/or EMA
Experience working on and supporting global clinical development programs; rare disease experience a plus
Internal Number: 062192
About Achillion, Inc.
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 therap...ies 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.