Regulatory Affairs Specialist

4 weeks ago

Short Hills, United States Katalyst HealthCares & Life Sciences Full time
Responsibilities:
  • Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports
  • Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers
  • Experience in reviewing of quality documents such as Reformulation studies, process validations, particle size method implementation and specification, stability indicating methods implementation, impurity < 1% qualification, repeating stability studies, in use stability studies, assay methods (anti-oxidant assay, anti-microbial agent assay), sterile filter testing, preservative effectiveness testing.
  • Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle as needed for product in-license/due diligence review, product divestment and product withdrawal.
  • Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
  • Planning the project by understanding the client needs, managing project deliverables and providing solutions in real time.
  • Collaborate with client and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
  • Manage execution / authoring of CMC documentation (Module 1 , 2 and 3) for life cycle management - post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
  • Knowledge of regulatory guidelines and relevant applications.
  • Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity.
  • Deliver all regulatory milestones for assigned products across the product lifecycle, Deliver on agreed SLAs with clients at contract and account/ project level. Meet all monthly reporting/business metrics/KPIs requirements and manage internal control processes.
  • Identify, communicate and escalate potential regulatory issues / risks and propose mitigation.
  • Ensure established policies and procedures of the organization/client are followed and ensure compliance.
  • Demonstrate oral and written communication skills and the ability to communicate issues in a succinct and logical manner.
  • Demonstrate ability to generate innovative solutions to problems and effectively collaborate with and communicate to key stakeholders.
  • Demonstrate flexibility in responding to changing priorities, multi-tasking and dealing with client expectations.
  • Demonstrate effective leadership, communication, interpersonal skills, and soft skills.
  • Qualifications we seek in you
Requirements:
  • Bachelor's or master's degree required in science, engineering or related field (advanced degree preferred).
  • Bachelor's or master's degree required in science, engineering or related field (advanced degree preferred).
  • Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields
  • Marketing authorization experience.
  • Proven Project Management experience

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