- Comprehends, manages, and executes the commercial Promotional Review Committee (PRC)/Medical, Legal, and Regulatory (MLR) review process, ensuring all tactical plans are implemented in compliance with the promotional guidelines and hold all stakeholders accountable by reinforcing the process
- Work with Marketing/Commercial to coordinate and prioritize materials for Promotional Review Committee (PRC) review
- Assist in organizing, scheduling, and hosting PRC meetings
- Perform operational tasks such as annotating within the Veeva PromoMats system to accurately capture all changes
- Perform final proofing of materials before proceeding to an approved status
- Provides 1:1 refresher training to internal and external stakeholders on PRC Policy and Procedures and PromoMats system user configurations, and actively works with colleagues to improve and update training
- Reviews Planning & Prioritization forecast trackers for all products and provides strategic guidance to Commercial and agency partners on submission timelines to meet critical business deadlines and launch initiatives. Challenges assumptions and help identify opportunities to optimize project execution
- Extracts raw data from PromoMats and provides a full analysis of process metrics, promotional material usage and offers recommendations based on findings
- Works with Commercial and external vendors to ensure inventory is managed and captured accurately within PromoMats and runs regular reports to cross-check with teams
- Collaborates with Regulatory to manage the workflow for label updates and ensures materials are updated appropriately, reviewed, and approved before the go-dark date
- Supports any technology implementations that improve or affect the PRC process
- Develops and maintains strong working relationships with internal and external stakeholders
- Tracks and test system configurations on an Ad Hoc basis
- Designs and implements effective and efficient project management tools and resources
- Oversee the preparation, submission, and tracking of regulatory documents to health authorities, ensuring accuracy, completeness, and timely submissions
- Collaborate with cross-functional stakeholders including Commercial, R&D, and Quality.
- Actively support any internal and external audits/assessments that may require access to regulatory records, information, or reports
- Bachelor's degree in a scientific or regulatory-related field
- 2-5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a focus on regulatory operations
- Strong understanding of Regulatory Operations processes and systems including Regulatory Information Management & Document/ Data Management
- Ability to work cross-functionally and with all levels of the organization, including Senior Leadership
- Experience with Veeva Vault digital asset management system a preferred
- Experience with Microsoft Office and Adobe systems
- Proven experience in leading and managing regulatory affairs operations teams.
- Strong team player, a professional capable of working collaboratively and independently, with excellent verbal and written communication skills
- Excellent project management and organizational skills
- Effective communication and collaboration skills
- Experience with regulatory submissions
- Remote-based position with occasional travel to conference meetings.
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Ardelyx Waltham, United States· Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA(tenapanor) and XPHOZAH (tenapanor), as well as e ...
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Regulatory Affairs Operations Specialist, Ad/Promo - Watertown, United States - Ardelyx
Description
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA(tenapanor) and XPHOZAH (tenapanor), as well as early-stage pipeline candidates.
Description (Remote Role)
As the Regulatory Affairs Operations Specialist, Ad/Promo, you will play a pivotal role in ensuring regulatory compliance and operational efficiency within our organization. This position requires a thorough understanding of pharmaceutical regulations, excellent project management skills, and the ability to lead and collaborate with cross-functional teams.
Key Responsibilities
Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.
Ardelyx is an equal opportunity employer.
