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Regulatory Affairs Senior Associate
Advanced Bio-Logic Solutions Corp Newbury Park , CA 91320
Posted 3 weeks ago
Description:Note:
- This will be a 100% remote role
- The hiring manager confirmed they are looking for someone who works regular hours (7a-4p or 8am-5p etc)/ with EST time zone preferred. Also as with the prior position, the candidate would need to have flexibility to shift their hours to start and end their day at a later time if additional support is needed for the PST time zone.
- As far as overall background, our team would need someone who is comfortable with learning new systems, has experience managing content in SharePoint, has working experience with the Six Sigma method and project management experience.
- Works well collaboratively, as there is a lot of teamwork involved in what we do.
- Detail oriented, to be able to monitor data quality.
- Comfortable learning new systems/processes. Someone who is able to follow instructions/guides, since we work in a framework based on rules/compliance.
- Science/Technology-based degrees are preferred OR industry-specific experience.
- If the candidate has experience in performing our team’s tasks and would be able to do this job, the type of degree would not necessarily matter.
- Good communication skills (verbal & written), resourceful critical thinker, detailed.
- (Overall, we’d need someone who understands the importance of details, since we work so much with monitoring Data Quality and someone who is able to communicate clearly with internal and external teams.
- Once training is completed, this individual must then understand how to utilize the tools provided to complete needed tasks, which requires resourcefulness and critical thinking skills.)
- Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives.
- Work with stakeholders to gather requirements and develop solutions.
- Provide Subject Matter Expertise in Veeva Vault Configuration and Regulatory Processes to a global user base.
- Develop and deliver training materials and presentations to a global audience.
- Author/review/approve quality Regulatory Information Management & Systems documents
- Analysis of the existing documentation and process explore avenues to simplify and streamline.
- Provide operational support for Regulatory Data Management, Submissions, and EU CTR.
- Develop and implement process improvements and automation.
- Lead and/or support team projects.
- Organize and present data in user-friendly, graphical, interactive informational summaries that illustrate how GRAAS is performing and allow us to understand and improve business performance.
- Utilize the Six Sigma method to support team processes.
- As the Global Labeling Lead product lead for marketed products, leads product-specific global labeling development and maintenance activities throughout a product?s life cycle.
- Specific responsibilities include: development and maintenance of Core Data Sheets and USPIs/ PPIs, facilitation of corporate review and approval activities for CDS and regional labeling, including regional deviations from the CDS.
- Ensures alignment of labeling strategy across products; collaborates with other Product Leads and functional area representatives to ensure adherence to established processes and corporate standards; coordinates corporate review and approval of cross-product issues within the scope of assigned products/franchises at the discretion of Director. Leads cross-functional teams in the development and maintenance of TPLs, dCDSs, CDSs, USPIs/PPIs/MGs/DHCP letters and Global Negotiation Documents (GNDs); facilitates implementation discussions of FDA approved product labeling; creates and maintains cumulative annotated labeling history documents for assigned products/regions; collaborates with regional affiliates and Business Partner representatives in the development and maintenance of regional drug product labeling; manages labeling commitments for Business Partners as delineated in partnership/service agreements; maintains awareness of regulatory legislation pertaining to labeling and assesses and communicates its impact on the business and products of the company; reviews and assesses impact of draft legislation; provides input on industry comments Technical: Proficiency in Microsoft Suite (Outlook, Word, Excel, PowerPoint) Technical competency for data entry into electronic document management systems, Share point sites and other databases/trackers.
- Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
- As far as overall background, our team would need someone who is comfortable with learning new systems, has experience managing content in SharePoint, has working experience with the Six Sigma method and project management experience.
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