Senior Regulatory Affairs Specialist
Rochester, NY Posted: 9/3/2021
Prepares and delivers regulatory strategic, tactical and operational plans for allocated projects/products. Project manages quality regulatory submissions to agreed project targets. Provides operational regulatory input and guidance in cross-functional teams. Works within and across regions to provide broad operational support to ensure the delivery of product team and business objectives.
ESSENTIAL DUTIES / RESPONSIBILITIES:
Completed Regulatory Submissions
- Plans, prepares, and delivers simple and complex submissions throughout the product's life cycle from either a global and/or regional perspective.
- Assists in developing and implementing strategies for the earliest possible approvals of regulatory submissions associated with assigned projects.
- Develops and implements regulatory strategies to support/maintain registrations.
- Reviews technical documentation and recommends changes as appropriate to ensure regulatory compliance and conformance to existing regulatory approvals.
- Acts as direct liaison with regulatory authorities to facilitate the prompt review and approval of applications.
- Regulatory Guidance & Advice (45%)
- Provides regulatory expertise for regulatory submissions, health authority briefing documents and response documents.
- Partners with project teams and other customer groups to ensure required regulatory contributions meet business needs and are provided to the project teams to agreed time, cost and quality standards.
- Ensures an aligned regulatory position is reached and communicated for all key issues for assigned projects; and that these regulatory positions supporting the business are championed and communicated.
- Develops and implements regulatory standards and SOPs.
- Analyzes and compares regulatory outcomes with initial product concepts and recommends future strategies and actions.
- Reviews change controls within timelines to identify regulatory reporting mechanism of proposed changes.
- Impact of Regulations Translated into Organizational Requirements (10%)
- Monitors and researches new and existing regulatory requirements. Stays current with FDA regulations affecting operations. Ensures organization is up-to-date on any changes and consults on the development/revisions of processes to accommodate changes.
- Maintains awareness of competitors" activities and shares the potential impact these activities may have on the product development program.
- Contributes toward the identification, development and implementation of enhanced processes to improve regulatory efficiencies.
Bachelor"s Degree in Science, Business or related discipline.
8 years pharmaceutical experience with knowledge of regional regulatory procedures and legislation related to one of the following: drug development, product registration, line extension or license maintenance. Additional experience with OTC products preferred. Experience with product labeling
- Ability to manage multiple priorities at once.
- Ability to be develop regulatory strategies that provide a completive advantage to the organization.
- Ability to effectively work in the grey areas of the regulations.
- Basic Outlook skills as evidenced by creating and sending messages, working with address books, message handling, creating and using personal folders, scheduling appointments, working with meeting requests and managing tasks.
- Basic Microsoft Word skills as evidenced by the ability to produce basic business letters and simple tables and charts; as well as check spelling, set tabs, change page orientation, sort, save, open and organize electronic files.
- Basic Excel skills as evidenced by the ability to use workbooks, create simple formulas, insert and delete data, create and edit charts, filter and sort lists, and format data.
- Basic PowerPoint skills as evidenced by the ability to create and save a presentation, add titles, edit and delete slides, reordering slides, applying slide masters, checking spelling, and adding clip art.
- Basic Microsoft Project skills as evidenced by the ability to assign resources and their work schedules to tasks, effectively use the different views, reports, and drawing tools, resolve time and resource conflicts, sort and filter information effectively and work with subtasks in an outline form, link tasks effectively and work with time constraints.
- Familiarity with ERP and TrackWise preferred.
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