Kaztronix
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As Sr. Manager, Regulatory Affairs, you independently provide strategic and operational global CMC regulatory direction and documentation for our products covering development and post-approval activities. You bring a foundation of regulatory knowledge and a collaborative, patient-focused mindset.
Your Responsibilities include, but are not limited to:
Minimum requirements
What you' ll bring to the role:
Sr Manager, Regulatory Affairs
Iselin, NJ US
Posted: 04/03/2023
2023-04-03
2023-06-27
Industry: Scientific
Job Number: 23-00137
Job Description
As Sr. Manager, Regulatory Affairs, you independently provide strategic and operational global CMC regulatory direction and documentation for our products covering development and post-approval activities. You bring a foundation of regulatory knowledge and a collaborative, patient-focused mindset.
Your Responsibilities include, but are not limited to:
- Formulate, lead and drive global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance for projects/products
- Lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products
- Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
- Author and/or review high-quality CMC documentation for submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements
- Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders. Represent department in cross-functional project teams
- Lead, prepare and communicate CMC risk management assessments and lessons learned on major submissions
- Initiate and lead Health Authority interactions and negotiations
Minimum requirements
What you' ll bring to the role:
- Education Minimum: Bachelors Degree or equivalent; advanced degree desired
- Minimum 3 years experience in PMO / Project Management
- Minimum 5 years of regulatory CMC experience and/or pharmaceutical industry experience
- Proven knowledge/experience in regulatory submission and approval processes and ability to deal with complex CMC regulatory issues and requirements
- Proven ability to critically evaluate data from a broad range of scientific disciplines
- Ability to handle complex CMC regulatory challenges and requirements while leading/working in interdisciplinary global teams
- Well-developed planning, organizational, negotiation, problem solving and interpersonal skills
- Strong oral and written communication skills with a collaborative and patient-focused mindset