Director of Regulatory CMC

JOB SUMMARY

The Director of Regulatory CMC will be based either virtual or based in Watertown or Boxboro Massachusetts and will be responsible for generating and managing regulatory submissions for the company (CMC content only) as well as working with and advising customers as to CMC strategy best practices to support their regulatory submissions. This position will support all regulatory activities in multiple jurisdictions (US and EU) to provide high quality CMC sections of regulatory documentation. The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on bringing a new generation of transformative medicines for patients. This role will report to the Chief Quality and Regulatory Officer.

ESSENTIAL JOB FUNCTIONS

• Develop and support effective CMC regulatory strategies for submissions 
  and identify regulatory risks
• Develop CMC modules/updates, including life cycle management, 
  generation of submission-ready content for customer’s clinical trial and 
  marketing authorization applications, and management of timelines, and 
  submission planning activities
• Forecast, manage, plan, and coordinate internal review of CMC 
  documentation for submissions and amendments, and other 
  communications with international regulatory authorities (e.g., briefing 
  documents for CMC meetings)
• Develop and maintain current CMC regulatory knowledge in 
  countries/regions of interest based on ICH guideline, regional guidance, 
  and best practices to set Reg CMC strategies for program teams.
• Play a key role in defining strategy for impurity control and establish 
  platform-based, phase appropriate specifications, analytical method 
  validations, etc
• Manage preparation and internal review of high quality Module 2 (QOS) 
  and Module 3 documents for IND/CTA/NDA/MAA as appropriate
• Interface with customers regarding regulatory CMC strategy and 
  development of content for regulatory submissions
• Author processes and SOPs in relation to regulatory operations and in 
  connection with other cross-functional procedures to achieve regulatory 
  submissions compliance and management

• B.A./B.S. degree in life sciences, MS is preferred
• 8+ years of direct experience in regulatory affairs specifically in CMC 
  documentation and CMC lifecycle management within the pharmaceutical 
  or biotechnology industry is a must;
• Experience in ATMPs early to late development phases required
• Experience in formatting, preparation and submission of CMC modules in 
  eCTD format, including variations and supplements, in the US and 
  international regions
• Excellent organizational skills, written and interpersonal communication 
  skills
• Ability to lead and work with others in a collaborative and empowering 
  manner
• Working knowledge of regulations of worldwide health authorities and ICH
• Proficient use of MS Office and project planning tools
• Very good prioritization skills to balance key priorities

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• The employee is frequently required to stand; sit; use hands to finger, 
  handle, or feel; reach with hands and arms; and talk or hear.
• The employee is occasionally required to walk; climb or balance; and 
  stoop, kneel, crouch, or crawl.
• The employee must frequently lift and/or move up to 10 pounds and 
  occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include close vision, and 
  ability to adjust focus.
• In the performance of the duties of this job the employee is required 
  to travel occasionally, drive a motor vehicle.
• Communicate using telephone and e-mail.