Manager/Senior Manager, CMC Regulatory Affairs

4 weeks ago

Waltham, 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

#LI-HB1

PDN-9bdf6f65-6e2b-4c28-8b8a-8b3e0e0268a8

  • Manager/Senior Manager, CMC Regulatory Affairs

    4 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...

  • Director, CMC Regulatory Affairs

    1 month ago

    Waltham, Massachusetts, United States Tscanrx Full time

    We are looking for an experienced CMC professional to join our team as a Director of CMC Regulatory Affairs supporting our growing pipeline of TCR T-cell therapies.The Director of CMC Regulatory Affairs will be responsible for supporting and leading the development and implementation of US, eventually global, CMC regulatory strategies for TScan's oncology...

  • Director, CMC Regulatory Affairs

    1 month ago

    Waltham, United States Alkermes Full time

    Overview: 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....

  • Director, CMC Regulatory Affairs

    22 hours ago

    Waltham, United States Alkermes Full time

    Job Description Overview: 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...

  • Director, Regulatory Affairs CMC Small Molecule, Mature Products

    1 week ago

    Waltham, United States GlaxoSmithKline Full time

    Site Name: USA - North Carolina - Research Triangle Park, Bangalore, India - Maharashtra - Mumbai, Poznan Grunwaldzka, UK - London - Brentford, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper ProvidencePosted Date: May 9 2024 Are you interested in a highly visible, global role that allows you to lead a team of regulatory experts while being part of...

  • Manager, Regulatory Affairs

    4 weeks ago

    Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Job Description The Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development. In this role, the Manager of Regulatory Affairs will support the regulatory lead on program related projects and be responsible for interacting with multiple functions to manage high quality regulatory submissions.  This...

  • Senior Director, Clinical Regulatory Affairs

    2 weeks ago

    Waltham, United States Dragonfly Therapeutics, Inc. Full time

    Senior Director, Regulatory Affairs Dragonfly Therapeutics is seeking a Senior Director, reporting directly to the Senior Vice President, Head of Regulatory Affairs, to join the regulatory team within our Regulatory Affairs organization. The primary responsibility of this role is to develop regulatory strategies for both non-clinical and clinical aspects,...

  • Senior Director, Clinical Regulatory Affairs

    2 weeks ago

    Waltham, United States Dragonfly Therapeutics Full time

    Senior Director, Regulatory Affairs Dragonfly Therapeutics is seeking a Senior Director, reporting directly to the Senior Vice President, Head of Regulatory Affairs, to join the regulatory team within our Regulatory Affairs organization. The primary responsibility of this role is to develop regulatory strategies for both non-clinical and clinical aspects,...

  • Director, Regulatory Affairs

    4 weeks ago

    Waltham, United States Dyne Therapeutics Full time

    Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...

  • Director, Regulatory Affairs

    4 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Director of Regulatory Affairs

    4 weeks ago

    Waltham, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Regulatory Manager

    22 hours ago

    Waltham, United States BostonGene Full time

    Position Summary BostonGene is seeking a Regulatory Manager to join our team and play a crucial role in supporting our ISO certification efforts and regulatory compliance. The primary focus of this position will be on ensuring Good Laboratory Practice (GLP) and ISO conversion for a team dedicated to assisting cancer patients using various molecular...

  • Regulatory Manager

    1 month ago

    Waltham, United States BostonGene Full time

    Position SummaryBostonGene is seeking a Regulatory Manager to join our team and play a crucial role in supporting our ISO certification efforts and regulatory compliance. The primary focus of this position will be on ensuring Good Laboratory Practice (GLP) and ISO conversion for a team dedicated to assisting cancer patients using various molecular...

  • Regulatory Manager

    4 weeks ago

    Waltham, United States BostonGene Full time

    Position SummaryBostonGene is seeking a Regulatory Manager to join our team and play a crucial role in supporting our ISO certification efforts and regulatory compliance. The primary focus of this position will be on ensuring Good Laboratory Practice (GLP) and ISO conversion for a team dedicated to assisting cancer patients using various molecular...

  • Regulatory Manager

    4 weeks ago

    Waltham, United States BostonGene Full time

    Position SummaryBostonGene is seeking a Regulatory Manager to join our team and play a crucial role in supporting our ISO certification efforts and regulatory compliance. The primary focus of this position will be on ensuring Good Laboratory Practice (GLP) and ISO conversion for a team dedicated to assisting cancer patients using various molecular...

  • Senior Director, GMP Quality Assurance, Commercial

    3 weeks ago

    Waltham, United States Taylor Strategy Partners Full time

    Description Sr. Director, GMP Quality Assurance, Commercial Position Summary: The Senior Director Quality Assurance will provide expertise and guidance on Good Manufacturing Practice for all commercial products. They will adhere to applicable regulations and work with stakeholders to proactively identify compliance issues and risks and implement corrective...

  • Senior Director, Regulatory Information Management

    7 days ago

    Waltham, United States Dyne Therapeutics Full time

    Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...

  • Senior Director, Regulatory Information Management

    1 week ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Vice President, Clinical Development

    2 weeks ago

    Waltham, United States Alkermes Full time

    This is a high impact position with great visibility across all levels of the Alkermes organization. The primary role is to drive Alkermes's clinical development portfolio in Neurology. Specifically, this position will have critical hands-on leadership responsibilities in the clinical department involved in the development of therapies for Neurology...

  • Executive Director, Clinical Development

    2 weeks ago

    Waltham, United States Alkermes Full time

    Position Overview This is a high impact position with great visibility across all levels of the Alkermes organization. This position will have critical hands-on leadership responsibilities in the clinical department involved in the development of therapies for neurology indications, including sleep disorders. Key domains include development of study...