Director of CMC Industry and Regulatory Intelligence

4 weeks ago

Troy, New York, United States BioSpace, Inc. Full time
Job Summary

The Director of CMC Industry and Regulatory Intelligence will play a critical role in enabling chemistry manufacturing and controls (CMC) quality and compliance excellence at BioSpace, Inc. This individual will be responsible for ensuring that the company maintains effective systems for monitoring, analyzing, communicating, implementing, and influencing global regulatory and industry trends, regulations, and pharmacopoeia.

Key Responsibilities:
  • Develop and implement strategies to translate CMC intelligence gathering into action and influence policy and standards for all CMC operations across the organization.
  • Collaborate with the Regulatory Intelligence and GMP Compliance and Inspections teams to support and drive activities that ensure appropriate regulatory intelligence and compliance information is maintained and made available throughout the organization.
  • Monitor and assess all sources of global CMC intelligence information, including industry trends, for relevance and impact to internal processes, drug development projects, and/or regulatory strategies.
  • Develop internal guidance, position papers, training materials, and communications to ensure leadership and staff are informed on regulatory compliance information, risks, and trends, and how existing procedures might need to be amended to remain in compliance.
  • Develop and implement strategies to ensure that products and processes are compliant with relevant regulations, collaborate with internal and external stakeholders, and provide guidance to teams across the organization.
  • Establish working groups, facilitate discussions, and lead presentations that examine regulatory intelligence and analysis of emerging trends and risks by bringing together subject matter experts from across all departments and levels to ensure compliance.
  • Engage in industry trade/professional associations in leadership positions to represent BioSpace, Inc. and influence the external regulatory environment.

Requirements

To be considered for this position, you must hold a bachelor's degree in life science, preferably related to health, environment, or politics, or a related degree. Additionally, you must have:
  • Associate Director: 15+ years of related experience in a regulated industry or health authority.
  • Director: 18+ years of related experience in a regulated industry or health authority.
  • Senior Director: 20+ years of related experience in a regulated industry or health authority.
  • Preferred Education: Relevant Master's degree in a scientific, health, legal, or business discipline. Regulatory certifications a plus.
  • Experience can be in lieu of education; leveling is decided on during an interview process.

About BioSpace, Inc.

BioSpace, Inc. is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

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