Overview:
The Manager, Regulatory Affairs CMC is responsible for defining and implementing global CMC strategies including regulatory relevant technical guidance to development teams and ensures adequacy of CMC documentation for global regulatory submissions.
The position supports and promotes all regulatory CMC tasks throughout the product lifecycle, in collaboration with internal and external stakeholders.
Responsibilities: Responsible for defining and implementing global regulatory CMC strategies, in-line with business objectives and in cooperation with key internal and external stakeholders.Responsible for leading the preparation/review and approval of regulatory submissions such as INDs, CTAs, IMPDs, NDAs, BLAs, MAAs and post-approval variations, annual reports, renewals and responses to health authority questions (deficiency letters).Accountable for the writing of regulatory CMC sections (e.g.
Module 2 and Module 3) from product development and quality source documents with following key activities:Lead compilation of regulatory submission packages in close collaboration with relevant stakeholders and applicable internal procedures.Ensuring that regulatory submission packages are scientifically adequate and include appropriate level of detail.Ensuring compliance with all applicable National and International regulations.Defining and implementing regulatory consultation strategy (e.g.
Scientific Advice, Pre-submission meetings and Health Authority engagement) including coordination of briefing package compilation if required.Provide strategic and technical guidance on regulatory CMC topics to product development teams and commercial manufacturing sites (e.g.
study protocols, study reports and technical plans).Ensure that regulatory risks identified during product development and/or post-approval are mitigated with the appropriate action plan(s) and incorporated into program management planning.Responsible for the regulatory evaluation of CMC change controls and maintaining product compliance throughout the product lifecycle.Provide regulatory CMC guidance in due diligence/commercial licensing activities.Manage external consultants and third-party vendors/providers in the execution and performance of regulatory activities.Responsible for the preparation and maintenance of department SOPs, KPI reporting and facilitate presentations to the mAbxience Executive Committee (MEC) on regulatory CMC strategy.Qualifications: Education: Degree in Life/Health Sciences (e.g.
Chemistry, Biology, Biochemistry, Pharmacy), or equivalent.
Advanced degree in Science preferred.
Languages: Fluent English required (oral and written); knowledge of Spanish and other languages will be an asset.
Experience (years/area): Minimum of 5 to 7 years experience in the pharmaceutical industry, including at least 3 years experience working within a Regulatory Affairs CMC function in biopharmaceuticals and/or biosimilars.Broad knowledge of global and national regulations, guidances, and policies in pharmaceutical and biologic drug development including ICH, FDA, and EMA.Experience in scientific writing, review and editing of CMC regulatory documents (INDs, CTAs, IMPDs, NDAs, BLAs, MAAs), including post-approval variations, annual reports, renewals and responses to health authority questions.Experience and knowledge of e-CTD requirements for submission to major authorities such as FDA and EMA.
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