Director/Senior Director Regulatory Affairs - CMC Director/Senior Director Regulatory Affairs - CMC …

Hamlyn Williams
in Philadelphia, PA, United States
Permanent, Full time
Be the first to apply
Competitive
Hamlyn Williams
in Philadelphia, PA, United States
Permanent, Full time
Be the first to apply
Competitive
Director/Senior Director Regulatory Affairs - CMC
Director/Senior Director Regulatory Affairs - CMC Small Molecule

Hybrid: 3 days a week in office

Location: Chester County, PA

Responsibilities include:
  • Lead and support the CMC aspects of regulatory planning and execution for my client's early to late development assets working with the cross-functional development and CMC teams.
  • Coordinating, authoring/preparing and reviewing CMC sections of IND/CTA, NDA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments to ensure applicable regulatory requirements are met.
  • Directing development of responses to all regulatory issues/queries involving CMC aspects of the development programs to achieve timely resolution.
  • Understanding, interpreting and advising teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new pharmaceutical products to assess risk/impact on business and development program/s.
  • Assessing data with technical functional expertise to solve problems and make good decisions for the overall business.
  • Building partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise and the provision of appropriate resources.
  • Coordinating, authoring/preparing and reviewing documents to ensure timely filing of CMC regulatory submissions (including INDs/CTAs, NDAs/MAAs, amendments/variations, safety reports, annual updates and briefing documents).
  • Guiding CMC stakeholders on regulatory issues and conducting impact assessment for manufacturing changes; maintaining records of the decisions per existing or new process to achieve compliance.
Candidate requirements:
  • BA/BS degree is required, Advanced degree preferred
  • Minimum of 5-8 years of experience in CMC Regulatory Affairs or related experience in positions of increasing responsibility, preferable in pre-marketing and post-marketing
  • Extensive regulatory experience including IND/CTA, NDA/MAA, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, developing and implementing complex regulatory CMC strategies with a proven track record of significant regulatory accomplishments. Experience preferred.
  • Experienced in Regulatory Agency meetings resulting in successful outcomes.
  • Knowledge and practical understanding of ICH Guidelines regarding GMP/GCP and CTD/eCTD, and US FDA CDER requirements for the drug approval process.
  • Previous participation in preparing Regulatory submissions (e.g., IND, CTA, NDA, etc.)
  • Solid understanding of the eCTD specifications for electronic submissions.
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