Director, Regulatory Affairs CMC

Location
Working from Home
Posted
Oct 14, 2021
Ref
330079
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

Reporting to the Executive Director of Regulatory Affairs, the Director of Regulatory Affairs CMC is responsible for the operational implementation of global regulatory strategies regarding the chemistry, manufacturing and controls (CMC) of approved drug products and those in development.

PRIMARY JOB FUNCTIONS

  • Collaborate with the Executive Management of Regulatory Affairs to develop regulatory strategies regarding CMC for investigational drug products and commercially approved products
  • Advise technical teams associated with the development and manufacturing of drug products on regulatory requirements to successfully implement regulatory strategies.
  • Maintain the CMC sections of regulatory submissions, including INDs, CTAs, NDAs, MAA
  • Author and/or manage technical writers for CMC regulatory documents
  • Review all protocols and reports used as source documents CMC documents for regulatory submissions
  • Interact with regulatory authorities as appropriate in the capacity of the CMC regulatory expert. Respond to Regulatory Authority requests for information.
  • Establish accurate plans and timelines for CMC sections of regulatory submissions
  • Work closely with Regulatory Operations to ensure CMC documents are of high quality and meet the requirements for inclusion in electronic or paper submissions as appropriate
  • As required, work with Quality Assurance to ensure CMC regulatory compliance during drug product development through approval, including but not limited to the development of operating procedures, maintaining training currency, and review of product complaints and of change controls for regulatory submission requirements.
  • Monitor and review new regulations and guidance documents concerning CMC and advise company management and staff of impact on the company’s development candidates and approved drug products.

ESSENTIAL QUALIFICATIONS & SKILLS

  • Bachelor degree
  • Minimum of 10 years in drug regulatory CMC positions of increasing responsibility in the pharmaceutical industry
  • 3 years experience in the management of staff, preferably in a drug regulatory affairs department
  • High level of knowledge of US CMC regulatory requirements.  Familiarity with regulatory requirements ex-US.
  • Past work experience in a technical CMC discipline e.g. manufacturing, product development, analytical development or QC is an advantage but is not required
  • Working familiarity of electronic regulatory submission requirements
  • Ability to work collaboratively and productively in a diverse, continually changing, and team-oriented organization
  • Ability to work independently with internal and external stakeholders at various levels
  • Excellent organizational, facilitation, and communication skills
  • Self-motivated and able to work from a home office environment
  • Demonstrated leadership capabilities and proactive problem-solver
  • Practical knowledge of MS Word, Excel, PowerPoint, and project management software
  • OTHER REQUIREMENTS

  • This role can be a work-from-home position operating on Pacific Standard Time
  • Some long-distance travel (10%) may be required with a potential of travel occurring over weekends
  • Flexible approach to time management with occasional work in evenings or over weekends as required
  • #LI-Remote