Director, CMC Regulatory Affairs

Found in: Talent US C2 - 2 weeks 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. 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 and is committed to providing the best strategy through dedicated teamwork, professional excellence, and collaboration at every opportunity.

The Director of CMC Regulatory Affairs will oversee and support development CMC team activities for an emerging portfolio of small molecule programs in neuroscience. 

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:

Managing, developing, and mentoring CMC Regulatory team responsible for supporting development programs Providing regulatory and scientific expertise to shape CMC strategies for development programs Ensuring high quality submissions for INDs, IMPDs, CTAs, and NDAs that align with company strategies and Health Authority requirements Working within the department and cross-functionally to establish regulatory CMC strategies for product development and commercialization Coordinating responses to CMC related inquiries from Health Authorities Leading and supporting preparation for key CMC related Health Authority meetings, including development of meeting information packages Fostering relationships and proactively communicating with key stakeholders Developing and implementing best practices based on current/emerging industry trends and relevant Health Authority guidance and regulations

Skills and Abilities:

In-depth understanding of relevant Health Authority regulations, guidelines and regulatory trends (FDA, EMA, TGA, Health Canada, ICH, ISO, WHO) In-depth knowledge of drug development process within pharmaceutical and/or biopharmaceutical industries Advanced writing skills with ability to deliver high quality regulatory documents

Basic Requirements:

Bachelor of Science in a scientific discipline; post graduate degree preferred  Related work experience in CMC Regulatory Affairs Previous related work experience in CMC drug development is required

Preferred Requirements:

Excellent oral communication skills Ability to influence decisions and help develop solutions  Commitment to continuous improvement and best practices Good judgement in identifying risks and elevating issues to Management

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