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Job

Director/Senior Director Regulatory Affairs - CMC

  • Location

    Philadelphia

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Tim Viola

  • Contact email:

    t.viola@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    25 days ago

  • Expiry date:

    2021-10-30

  • Startdate:

    ASAP

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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