Sr Manager, Regulatory Affairs

Iselin, NJ

Posted: 04/03/2023 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
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
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