Manager/Senior Manager, CMC Regulatory Affairs

2 weeks ago

Waltham, Massachusetts, United States Alkermes, Inc. Full time

Great Science.Deep Compassion.Real Impact.

Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, and addiction.

We are inspired by the courage and determination of individuals living with complicated and often difficult-to-treat diseases. We have a portfolio of proprietary marketed products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, and neurological disorders.

Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs supports a portfolio of small molecule development programs and marketed products across multiple locations andis committed to providing the best strategy through dedicated teamwork, professional excellence, and collaboration at every opportunity.

The Manager/Senior Manager of CMC Regulatory Affairs will be responsible for supporting commercial CMC and GMP activities for contracted manufactured products and Alkermes' European office. This role will represent Regulatory Affairs at client meetings, cross-functional meetings and various project teams.

Additionally, this role will have future involvement in supporting Alkermes' products to ensure high-quality submissions for INDs, IMPDs, CTAs, and NDAs that align with company strategies and Health Authority requirements. The Manager/Senior Manager will also participate to formulate regulatory CMC strategies for product development and commercialization.

This position is eligible for a hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office. This role is not eligible for fully remote work.

Key responsibilities of this role include:

  • Lead regulatory interactions with third-party clients, serving as the primary liaison.
  • Coordinate with contract manufacturing facilities to procure required documentation to support third-party licensing activities, ensuring timely provision of documentation for client regulatory compliance.
  • Manage the collection, review, coordination, and preparation of documentation for regulatory CMC submissions, including maintaining comprehensive trackers for documentation requests and timelines.
  • Oversee the maintenance of Drug Master Filings (DMFs), including review, preparation , and updating of CMC information and annual reports.
  • Represent Regulatory Affairs in various internal cross-functional project teams, improvement initiatives and providing regulatory positions on various CMC related topics.
  • Review and approve change controls related to proposed product/process changes and assessing their impact on specific regulatory requirements.
  • Maintain and update regulatory compliance documentation for Alkermes' European office, including site authorizations and site master file, in collaboration with cross-functional teams.
  • Lead efforts to enhance regulatory standards and initiatives.
  • Cultivate productive working relationships with the Regulatory team and other departments.
  • Monitoring changes in regulations and disseminate relevant information and impact across the organization.
  • Define departmental operating standards and ensure adherence to essential procedures
  • Foster relationships and proactively engage with key stakeholders.
  • Coordinate responses to CMC-related queries from Health Authorities
  • Develop and implement best practices based on current/emerging industry trends and relevant Health Authority guidance and regulations.

Skills and Abilities:

  • Understanding of relevant Health Authority regulations, guidelines and regulatory trends (FDA, EMA, TGA, Health Canada, ICH, WHO)
  • Strong writing skills with ability to deliver high quality regulatory documents
  • Excellent judgement in identifying risks and elevating issues to Regulatory Management

Basic Qualifications:

  • Bachelor of Science in a scientific discipline; post graduate degree preferred
  • Related work experience in CMC Regulatory commercial and drug development is required
    • Manager: 5+ years' of experience
    • Senior Manager: 6+ years' of experience

Preferred Qualifications:

  • Excellent verbal communication skills
  • Excellent attention to detail
  • Self-starter and ability to work under tight deadlines.
  • Ability to work effectively in a team/matrix environment
  • Ability to influence decisions and help develop solutions
  • Ability to cope with changing priorities
  • Excellent problem-solving skills
  • Commitment to continuous improvement and best practices

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