full time legal management senior

Job Details

Job Description Summary: The Senior Manager, Regulatory CMC Technical Writing provides CMC technical support for submission of CMC regulatory documents to regulatory authorities. This includes but is not limited to: leading the preparation of, authoring, editing, content verification, and providing input to CMC-related documents required for regulatory submissions to global health authorities. The incumbent works closely with Regulatory CMC Strategists, cross-functionally with internal departments and external resources on CMC Technical Writing related issues. The Senior Manager, Regulatory CMC Technical Writing will collaborate on the development of CMC-related documents in accordance with all applicable regulations including, but not limited to Good Manufacturing Practice (GCP), applicable regulatory requirements and guidance documents (e.g., 21 CFR Parts 312 and 314, European Medicines Association (EMA) Clinical Trials Directives, International Congress on Harmonisation (ICH... guidelines) company Standard Operating Procedures (SOPs) and internal style guides, as appropriate.Job Description:Responsibilities:Leads analysis, and interpretation of CMC-related technical data (from SOPs, Batch Records, Reports, etc.) to author CMC dossier content for clinical trial applications (eg INDs/IMPD) and marketing applications (eg NDA/BLA/MAA), and other documents needed to support regulatory interactions and filings for CMC for small molecules and/or biologics.Performs editorial review of documents prepared by other team members for completeness, accuracy, consistency, structure, and grammar.Coordinate authoring and review activities with Regulatory CMC leads, Technical Operations and Quality Assurance to reach alignment and to meet deadlines for Regulatory submissionsParticipates in key cross functional meetings to align on general strategy for content and authoring of documents.Work closely with Regulatory Affairs to establish priorities and ensure successful completion of regulatory submissions to Regulatory Operations.Ensures key messages are clear and consistent within and across documents.Ensures a consistent style of document presentation to maintain quality and ease of review and adherence to company standards.Contributes to the development and standardization of templates and related processes.Assists in the day-to-day operational activities and other assignments as needed and specified by management.Qualifications:Advanced degree (PhD, PharmD, or MS) with 5+ years in pharma/biotech industry with at least 3 years for regulatory CMC writing experience in pharmaceutical industry OR Bachelors degree in a scientific discipline with 7+ years of experience in a pharmaceutical, biotechnology, or CROs. Extensive experience in a CMC writing role, including participation in initial and/or post approval submissions to the US FDA (IND, NDA, BLA) and/or EMA (IMPD, MAA).Broad knowledge of ICH, EMA, and FDA guidance beyond those pertaining to specific regulatory documents.Excellent attention to detail, including fact checking, logical flow, parallelism, formatting, and document structure.Ability to influence without direct authority.Proficiency with Microsoft Office and use of and Electronic Common Technical Document (eCTD) templates.Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.0-10% travelOffice-based or remote as necessaryEEO Statement: PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.Click here to return to the careers page

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