Director, CMC Regulatory Affairs

Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative
medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role.  We are creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, fibrosis and anemia. 
 
Scholar Rock’s newly elucidated understanding of the molecular mechanisms of growth factor activation enabled it to develop a proprietary platform for the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level.  By developing product candidates that act in the disease microenvironment, we intend to avoid the historical challenges associated with inhibiting growth factors for therapeutic effect. Our lead product candidate, SRK-015, is being developed for the treatment of patients with Spinal Muscular Atrophy (SMA).

Summary of Position:
Here is your opportunity to join a patient-inspired, creative, collaborative, fun and experienced team. Our mission is to help patients with serious illnesses by applying innovative thinking, explore cutting edge science, and drive our passion towards discovering and developing novel therapeutics.  Playing a critical role within Scholar Rock, the Director, CMC Regulatory Affairs will provide product strategy and direction to internal teams as well as with global health authorities for all CMC related topics.  This position requires a highly motivated and enthusiastic regulatory professional with hands-on expertise in taking novel compounds from clinical candidate nomination through proof-of-concept and beyond. Key success factors for the position include biologics experience, creativity, integrity in thought and action, team-centric mindset, integrative thinking, ability to influence decision-making, exceptional communication skills, the ability to inspire, and being a “hands-on doer”.
 
 Position Responsibilities: 
  • Lead/manage regulatory CMC strategy and submission aspects for development programs. 
  • Provide critical review of the CMC data packages from other functional team representatives to support IND/CTAs.
  • Work with CMC functional experts to provide timely responses to CMC regulatory questions from FDA and global health authorities.
  • Leads and/or participates in regulatory interactions with FDA and global regulatory agencies with respect to CMC topics.
  • Collaborate with Quality Assurance to manage programs and ensure regulatory compliance during product development, validation, and commercialization.
  • Ensure compliance to global regulatory requirements, regulations and laws, as well as internal policies and procedures.
  • Maintain current knowledge of relevant US and international guidance, laws and regulations, and proposed and final rules which affect CMC pharmaceutical drug development.
  • Participate in outside professional development meetings and conferences to ensure the latest thinking is applied to CMC strategies.
 
Candidate Requirements:
  • Minimum of BA/BS degree is required. Advanced degree (M.S. or Pharm.D.) in scientific or related pharmaceutical field preferred.
  • A minimum of 8-10 years of experience in regulatory affairs CMC or a related pharmaceutical development field. Experience with regulatory CMC aspects of large molecule drugs preferred. Experience with global clinical trial and marketing applications, eCTD submissions and electronic document management systems, highly desirable.
  • Proven ability to prepare and submit documents to FDA and global health authorities, such as, Investigational New Drug Applications (IND), Marketing Authorization Applications (MAA), Clinical Trial Applications (CTA) / Investigational Medical Product Dossier (IMPD). 
  • Strong writing, project management and communication skills. 

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