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Sr/Director Regulatory Affairs CMC

Company: Apex Systems
Location: Cambridge
Posted on: June 6, 2021

Job Description:

Head/Senior Director, Regulatory CMC 1151583

Job Scope & Purpose:

Our gene therapy focused client is seeking a creative and strategic Head (Director/Senior Director), Regulatory CMC who will be responsible for cross-functional collaboration in preparing CMC and Quality related health authority correspondence and regulatory submissions. Our client fosters a collaborative and transparent culture as they develop lifesaving, novel technologies. This is a fantastic opportunity to experience the positive culture of the organization while contributing to the development a high-functioning regulatory team.

Primary Job Responsibilities:

  • Provide regulatory CMC strategic leadership within Regulatory and on cross-functional teams to support development of innovative therapies.
  • Develop and proactively communicate regulatory CMC strategies, risks and key issues.
  • Act as the regulatory CMC lead and department representative in matrix teams for development programs.
  • Support development of manufacturing, analytical, and supply chain strategies and provide regulatory guidance for global implementation.
  • Define CMC content requirements for quality sections of regulatory dossiers (IND/CTA/MF and BLA/MAA).
  • Plan and manage activities for the preparation of CMC-related global regulatory submission elements, including authoring and/or critical review to ensure compliance with regulatory requirements in accordance with program timelines.
  • Providing review of scientific information in CMC documents.
  • Evaluation of CMC-related change proposals for regulatory impact and filing requirements; provide strategic regulatory guidance for the implementation of changes.
  • Develop regulatory processes and procedures to support CMC sections of regulatory submissions.
  • Support the creation and maintenance of CMC submission templates and dossier standards.
  • Lead and support global health authority interactions and strategies for CMC-related topics.
  • Support Quality Assurance in preparing and hosting GMP inspections.
  • Develops and maintains collaborative partnerships with key internal and external stakeholders.
  • Participate in regulatory intelligence activities, monitor regulatory guidelines and trends as they pertain to global CMC regulations and guidance.

Primary Job Requirements:

  • BA/BS degree in a scientific/engineering discipline.
  • 10+ years' experience in the Pharmaceutical/Biotech industry.
  • 5+ years' experience in Regulatory CMC, or related experience (e.g., manufacturing, analytical, quality assurance) as a strong dossier preparation contributor for IND/CTA/MF and BLA/MAA submissions.
  • Comprehensive knowledge of regulatory (FDA. EMA, and ICH) guidelines; with a demonstrated ability to apply principles to regulatory CMC strategies for novel products.
  • Diverse experience including drugs, biologics, devices and international filings preferred.
  • Experience with CTD format and content regulatory filings.
  • Excellent written/oral communication, and time management skills.
  • Experience with related CMC disciplines (e.g., manufacturing, analytical, quality assurance) and able to apply diverse problem solving.
  • Ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

sscheipers@stratacuity.com

Code: RegQA

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.

Keywords: Apex Systems, Cambridge , Sr/Director Regulatory Affairs CMC, Other , Cambridge, Massachusetts

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