Regulatory Systems Manager
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Job Location:
Newark, DE - USA
Monthly Salary:
$ 117000 - 143000
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
Description
Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative purpose-driven culture we strive to create meaningful impact for patients.
Team Ardelyx is united by a shared mission and guided by our core values: Passionate Fearless Dedicated and Inclusive.
We foster an inclusive environment where employees are respected supported and empowered to make an impact both within our company and in the lives of patients we serve.
Team Ardelyx is united by a shared mission and guided by our core values: Passionate Fearless Dedicated and Inclusive.
We foster an inclusive environment where employees are respected supported and empowered to make an impact both within our company and in the lives of patients we serve.
Position Summary:
The Regulatory Systems Manager is responsible for the administration optimization and day-to-day management of regulatory systems that support global regulatory operations. This role will ensure regulatory information and documentation are maintained accurately and efficiently across systems that support regulatory submissions health authority interactions and product lifecycle management.
This position is hands-on working closely with Regulatory Affairs Quality and IT teams. The Regulatory Systems Manager will play a key role in improving processes ensuring data integrity supporting system implementations configuration or upgrades and enabling efficient regulatory submissions and compliance.
Responsibilities:
- Serve as the primary business owner and administrator for regulatory systems (e.g. regulatory information management systems document management systems and submission publishing tools)
- Manage system configuration user access permissions workflows and data governance to ensure accurate and compliant regulatory records
- Oversee system upgrades releases validation activities and change control processes including maintaining regulatory product data submission data and health authority correspondence within systems
- Develop and maintain standard operating procedures (SOPs) system documentation and training materials
- Support the preparation and management of global regulatory submissions by ensuring systems and document structures align with submission requirements
- Partner with Regulatory Affairs teams to track global regulatory commitments submissions approvals and lifecycle activities
- Ensure global regulatory documentation is properly archived and maintained in accordance with company policies and regulatory requirements
- Provide user training and ongoing support for regulatory teams using Veeva RIM (Registrations Submissions or Archive modules)
- Act as the point of contact for system questions troubleshooting and process guidance and vendor coordination
- Act as the Regulatory Affairs representative in systems improvement projects with IT and external vendors including performing system testing validation support and user acceptance testing (UAT)
- Ensure regulatory systems operate in compliance with applicable regulatory requirements and internal policies
Qualifications:
- Bachelors degree in regulatory affairs information systems or related field with 5 years of experience in regulatory operations or regulatory systems or equivalent experience within the pharmaceutical biotech or life sciences industry.
- Experience administering and/or supporting regulatory systems such as Veeva Vault RIM particularly Registrations and regulatory data management or submission publishing tools
- Experience supporting global regulatory submissions and product registration tracking
- Strong understanding of regulatory operations and regulatory document lifecycle
- Experience working in GxP regulated environments
- Strong attention to detail with focus on data integrity and compliance
- Excellent organizational communication and cross-functional collaboration skills
- Experience supporting system implementations configuration or upgrades is preferred
- Certification or training in Veeva Vault platform
The anticipated annualized base pay range for this full-time position is $117000 - $143000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors including years of relevant experience training qualifications and internal equity. The compensation package may also include an annual bonus target and equity awards subject to eligibility and other requirements.
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 of 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.
Required Experience:
Manager
About Company
From discovery through commercialisation, all of us at Ardelyx are driven to advance targeted therapies where significant medical needs persist.
