Title:
Senior Specialist, Regulatory Publishing
Company:
Ipsen Bioscience, Inc.
Job Description: Summary / purpose of the position:
We are seeking an experienced, in-house Senior Specialist, Regulatory publishing professional who can prepare and submit a variety of submissions with high quality.
This role often involves working closely with regulatory affairs teams, medical writers, and other stakeholders to ensure that all necessary documentation is prepared and submitted to regulatory authorities.
And ensure archival activities of submissions with limited supervision.
In this position, you will participate in various activities as part of a dynamic and evolving Regulatory Operations team.
The Senior Specialist must be a creative, resourceful, integrative thinker.
Main responsibilities / job expectations: Responsibilities will include, but are not limited to the following: Coordinate and manage the preparation of regulatory submissions, ensuring they meet all required standards and deadlines. Independently prepare and submit eCTD and non-eCTD submissions of varying complexity to IND/CTA and NDA/MAA applications Format MS Word and Adobe Acrobat files to a state of submission-readiness. Review and perform quality check of the published submissions to ensure accuracy and completeness. Identify and resolve issues related to regulatory submissions, such as missing information or delays. Provide support to Regulatory Affairs and other Project stakeholders in the creation of documents required for a submission. To dispatch submissions to health authorities using electronic submissions gateways. Preparation of submission binders in electronic document management system (EDMS) Collaborate with cross-functional teams to gather necessary information and ensure timely submission. Contribute to the writing, review, and implementation of standards, templates, and procedures related to the publishing, review, transmittal, and archiving of electronic regulatory documentation; and help implement associated process improvements.
Stay up to date with evolving regulatory requirements and ensure that all submissions comply with relevant regulations. Knowledge, abilities & experience: Education and Qualifications: Bachelor's degree required or equivalent experience. Preferred Experience: 2+ years of relevant Regulatory Operations experience in biotech/pharmaceutical industry Strong understanding of submission requirements, Records management concepts, and electronic tools and systems. National /centralized EU submissions Grouped and OPDP Submissions experience. ISI ToolBox/ Acuta PDF/other Adobe plug-ins Veeva/other EDMS Extedo eCTDManager (preferred) and other publishing tools Languages: Fluent in English Key Technical Competencies Required: Expert-level document formatting and submission building (eCTD and non-eCTD) Experience with electronic submission platforms Proficiency in Microsoft Word, Microsoft Excel, Acrobat Professional, and SharePoint Ability to work with firm deadlines and adapt quickly to changing requirements and priorities. Excellent organization, written/verbal communication, and attention to detail. Strong attention to detail Ability to work independently and as part of a team.
The annual base salary range for this position is : $71,250 - $104,500
This job is eligible to participate in our short-term incentives program.
At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts.
Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.
The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting.
Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.
IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination.
We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination.
We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.