Responsibilities:

• Gathers, prepares (as needed) and assembles the essential documents from internal teams and/or external Clinical Research Organizations (CROs) required for global regulatory submissions; confirms the accuracy and quality of submission content, obtains required approvals and ensures that the documents are submitted in accordance with regulatory and internal standards.
• Publishes electronic submissions in Electronic Common Technical Document (eCTD), or non-eCTD format, for FDA, EMA and other regulatory agencies. This may include source document formatting, internal hyperlinking and bookmarks and sequence level publishing. This may also include managing third party publishing vendors to ensure submission timelines are met. The range of submission types includes, but is not limited to, Investigational New Drug applications (INDs)/Clinical Trial Applications (CTAs), Protocol Amendments, Safety Reports, Chemistry, Manufacturing and Control (CMC) Amendments, New Drug Applications (NDAs), Health Authority Meeting Briefing Packages, Labelling, and Responses to Agency Queries.
• Maintains and tracks regulatory submission documentation (hard copy or electronic), including regulatory authority correspondence, in an appropriate document management system or hardcopy archive location to ensure regulatory compliance and in accordance with company document standards.
• Acts as a liaison with external, third-party organizations to provide regulatory support for the completion of outsourced regulatory submissions.
• Contributes to the development of SOPs, Work Instructions (WIs) and training materials required to support the activities. Updates internal processes to ensure compliance with health authority requirements and expectations.
• Demonstrated understanding of clinical trial conduct, data acquisition, and reporting.
• In-depth knowledge of CFR (Title 21) and International Conference on Harmonisation (ICH) guidelines including thorough knowledge of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) policies and procedures.
• Understanding of the Quality Assurance (QA) function as it applies to regulatory documents including the ability to review and QC documents intended for regulatory submissions.
• Provides end-user support for eDMS-based applications including conducting requisite training for eDMS users. Performs other tasks and assignments as needed and specified by management.

Qualifications:

• Bachelor's degree in a relevant discipline and a minimum of 6 years progressively responsible experience in a pharmaceutical, biotechnology or contract research organization (CRO) or related environment OR equivalent experience and/or education.
• Hands-on experience in the process of generating, reviewing and formatting documentation for worldwide regulatory submissions.
• Demonstrated expertise utilizing the eDMS applications used for regulated document control, preferably in a pharmaceutical or biotechnology company.
• Proficiency with use of ISI Toolbox.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication and skills.
• 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.
• Experience supporting or administering eDMS-based applications used for regulated document control, preferably in a pharmaceutical or biotechnology company. (Veeva RIM).
• Experience with eCTDXPress.
• MS-Project
• Project Management Professional (PMP) Certification.
• Travel requirements: 0-10%

EEO 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.

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