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Company

Original Job Post

Asklepios BioPharmaceutical, Inc. (AskBio) · 2 days ago

Associate Director, Regulatory Operations

United States

Full-time

Remote

Director

7+ years exp

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BiopharmaBiotechnology

H1B Sponsorship

Growth Opportunities

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Responsibilities

Provide operational oversight for the planning, preparation, formatting, publishing, and timely submission of assigned submissions to regulatory agencies.

Define submission scope, goals, and deliverables, plan submission timelines, and coordinate submission timelines for regulatory deliverables.

Liaise with project stakeholders to track project milestones, develop deadlines, and prepare progress reports.

Support cross-functional project teams with submission guidance and ensure high-quality submissions.

Oversee archiving of regulatory submissions, develop submission process improvements, and ensure adherence to submission standards.

Attend project team meetings, support the implementation of the company's Regulatory Information Management system, and participate in standard setting for efficient processes.

Qualification

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Regulatory OperationsPharmaceutical Industry KnowledgeExperience in publishingCompilation of eCTD submissionsExperience working with external publishing vendors CTD/eCTD structure submission requirements for global submission types Microsoft Office suite Adobe Acrobat Adobe Plug-Ins eCTD publishing tools eCTD validationViewing tools SharePoint technology project management tools document management systems StartingPoint templates advise teamsManagement of impactsChanges in project timelinesProblem-solvingHard-working verbalWritten communication interpersonal skills build relationships training skillsDemonstrated project managementOrganizational skillsPlanning skills

Required

A minimum of a Bachelor’s degree in a scientific or technical discipline

A minimum of 7+ years of experience in regulatory operations within the pharmaceutical industry

Preferred

Experience in publishing and compilation of eCTD submissions for US and EU filings and experience publishing electronic submissions in other regions is desirable

Experience working with external publishing vendors desired

Expertise in CTD/eCTD structure and requirements and an excellent understanding of submission requirements for global submission types (e.g., IND, NDA, MAA, NDS, CTA, DSUR, PSUR, REMS, etc.)

Excellent verbal and written communication and presentation skills. A strong training skill is a plus

Very strong interpersonal skills and ability to build relationships with cross-functional teams

Superior knowledge of Microsoft Office suite, Adobe Acrobat, Adobe Plug-Ins (PDF Tools, Toolbox, etc), eCTD publishing tools, eCTD validation and viewing tools. Solid experience and knowledge of SharePoint technology and project management tools are desired. Experience with document management systems such as Veeva Submisison/Submission Archive desirable

Strong knowledge of StartingPoint (or similar eCTD authoring) templates

Demonstrated project management, organizational and planning skills

Ability to multi-task, attention to details, and end-result driven with meeting deadlines

Ability to work independently (with minimal supervision), as well as work in a team environment with changing timelines and priorities

Must be able to adhere to strict project timelines, and to advise teams and management of impacts and changes in project timelines

Good understanding of the internal and external interdependencies among submission activities that could have an impact on the schedule or quality of a submission and manage to ensure that submission goals are met on a timely manner and to the highest quality

Company

Asklepios BioPharmaceutical, Inc. (AskBio)

Asklepios BioPharmaceutical, Inc.

Founded in 2001

Chapel Hill, North Carolina, USA

501-1,000 employees

http://www.askbio.com/

H1B Sponsorship

Asklepios BioPharmaceutical, Inc. (AskBio) has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (1)

2022 (10)

2021 (3)

2020 (2)