As an individual contributor, the function of an RA Associate will combine knowledge of scientific, regulatory/business issues to provide support to complete product dossiers, technical files, and responses to information requests required in order to market products internationally.
Duties include coordinating/completing documents required by regulatory agencies, maintaining complex files and electronic document management systems, and working with project teams to maintain/obtain approval for registrations. The individual will be responsible for the maintenance of global registration information in the various software management tools used throughout the RA org. Using these software systems, the individual will be responsible for the generation of metrics and data reports to measure compliance with the system requirements, support system enhancements, and training of various user groups. The individual may execute tasks and exercise influence generally at the global peer level.
- Serves as primary interface with the Area and Affiliate regulatory team to coordinate/complete international regulatory documents and product sample requests in order to register/market products internationally. Responsible for products manufactured in the US and Puerto Rico. Serves as the primary point of contact with the FDA to complete documentation/ legalization requirements for requests related to US/PR released products.
- Coordinates all documents requiring legalization needed to support global marketing authorizations, including developmental/on-market product applications. Assembles information and submit to U.S. FDA to prepare Certificate of Pharmaceutical Product (CPPs). Liaises with contract organization to process legalizations. Maintain tracking of invoices to provide budget updates to mgmt.Assists regulatory staff in prep and legalization of Power of Attorney (POAs) and Letters of Authorization (LOA)
- Provides routine status updates on legalized document and product sample requests to ensure that all submission timelines are met.Updates and maintains global product listings, facility registrations, licenses/approvals, and annual registrations. Obtains finished product samples, reference standards, test equipment and labeling to support registration requirements of Affiliates.Accountable for continuous improvement efforts to meet service, quality and resource objectives.
- Identify areas for improvement to systems, project plans and processes. Represent the GSSC team on projects to address system, project and process improvement initiatives.This individual is accountable for the assigned module 1 deliverables globally.BPO for all GSSC tool initiative with IT for system improvements and enhancements to capture data right first time
- This individual will interact with all Area Regulatory Product Leads and participate in the dossier kick off meetings and be responsible for providing the following:Input to the development of submission strategy, provide expertise feedback with regards to specialty documentation and registration sample requests.As required, status updates including identifying and evaluating any possible risks to submission timelines and possible options for resolution.
- Serves as “super user” of data management tool (Launch Excellence) used by cross-functional teams to monitor the progress and readiness for launch of new brand products and other specific Regulatory Milestones.
- Full administrative rights to the data management tool in order to participate in new template development, suggestions for IT enhancements, maintenance of affiliate access and ability to update affiliate contact lists.Ensures accurate data is being loaded into the data management tool by performing quality checks of new project entries and generating various reports to demonstrate compliance with system requirements.
- Ensures all business critical milestones are correctly entered into the system to guide the Affiliate and Global cross-functional teams in prioritizing their activities. Trains launch teams and functional leaders on launch tool and process. Helps with onboarding and training of new staff.
- Bachelor's degree in in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required. Relevant advanced degree in life sciences is preferred.5+ years extensive experience in Emerging markets and pharmaceutical industry or related 5+ years regulatory experience.
- Extensive pharmaceutical industry experience in Regulatory Affairs or R& D, with experience in Regulatory Affairs in developed and Emerging markets.Must be able to work in a global environment and work virtually with members of area and affiliate teams.
- Cross culturally competent.Must maintain collaborative relationships with Product Support, R&D, Operations, Quality and TPM partners.
- Completes daily work to meet established schedule with minimal guidance from supervisor on prioritization of tasks.The ability to multi-task and adjust work activity immediately is essential.
- Changes to policies or requirements must be raised to manager. Outcome may be a routine decision that can be handled by the coordinator.Participate in dialogue/discussion with A&A regulatory team members to understand document/sample requests and provide consistent updates on status.
- Liaise with FDA to coordinate issuance and legalization of documents to support global submission requirements.
- Experience with Microsoft Office suite, most notably with excel, word, and Outlook.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Job Type: Experienced