Regulatory Submissions Coordinator, Biological Products
Location
Mexico
Posted
5 days ago
Salary
0
Seniority
Senior
Job Description
Regulatory Submissions Coordinator, Biological Products
Parexel
• Support the coordination, preparation, and delivery of regulatory submissions and lifecycle management (LCM) activities • Assist in organizing submission team meetings • Coordinate, request, and track documentation from Subject Matter Experts (SMEs) • Support the preparation and maintenance of the Submission Content Plan (SCP) • Ensure timely dispatch of non-eCTD submission packages • Provide hands-on operational support for labeling activities • Prepare annotated labeling documents for regulatory review • Initiate and coordinate mock-up requests in the Artwork Management System • Track print releases as required • Support change control activities related to local labeling updates • Ensure appropriate archiving of labeling documentation • Support the creation, maintenance, and accuracy of submission and regulatory records in regulatory systems • Upload Module 1 and non-eCTD submission documents to DocNet • Update regulatory systems with Health Authority interactions • Provide regular status updates to the Regional Submission Coordinator (Lead) • Support tracking of submission milestones, deliverables, and dependencies • Collaborate effectively with cross-functional teams • Perform assigned activities in compliance with applicable SOPs, work instructions, and regional regulatory requirements
Job Requirements
- Bachelor's degree in Life Sciences, Pharmacy, or a related discipline
- Associate: 1–3 years of experience, Sr Associate +3 years in regulatory affairs, regulatory operations, or a related pharmaceutical/biotechnology role
- Experience with Biological Products (Mandatory)
- Experience with regulatory submission processes and lifecycle management activities
- Experience with Veeva RIM and document management tools
- Effective written and verbal communication skills in English and Spanish (mandatory)
- Strong organizational skills with attention to detail and quality
- Ability to manage multiple tasks and timelines in a matrix environment
Benefits
- Health insurance
- 401(k)
- Flexible work arrangements
- Paid time off
- Professional development
Related Guides
Related Categories
Related Job Pages
More Compliance Jobs
Privacy and Compliance Analyst
BIS Safety SoftwareEHS software for the Safety Professional US website - https://www.bissafety.com/ UK website - https://www.bissafety.uk/
• Execute Risk & Compliance Initiatives: Manage and deliver privacy, security, and compliance projects, ensuring alignment with organizational goals and timelines. • Identify and Mitigate Risks: Proactively assess operational, IT, and data privacy risks, partnering with cross-functional teams to implement effective mitigation strategies. • Build and Improve Frameworks: Develop, maintain, and enhance compliance frameworks, policies, and procedures aligned with evolving regulations (PIPEDA, COPPA, GDPR) and industry standards. • Support Audits and Assessments: Coordinate third-party audits (e.g., SOC 2, PCI DSS) and conduct internal assessments to ensure ongoing compliance. • Strengthen Security Practices: Support software security improvements and contribute to initiatives that enhance controls and reduce risk exposure. • Manage Security Incidents: Lead or support incident response activities, including investigation, documentation, communication, and remediation. • Review and Resolve R&C Requests: Triage and respond to compliance-related tickets and inquiries, providing timely guidance and solutions to internal teams. • Research and Apply Regulatory Standards: Stay current on privacy laws and industry requirements, translating them into practical policies and operational processes. • Communicate and Report: Prepare clear, accurate compliance documentation and reports for internal stakeholders, clients, and auditors. • Engage with Stakeholders: Liaise with clients, vendors, auditors, and internal teams to address compliance requirements and support ongoing initiatives. • Deliver Training and Awareness: Support training efforts and help foster a culture of data security and compliance across the organization.
Compliance Analyst
Crum & ForsterCrum & Forster, part of Fairfax Financial Holdings Limited, is an admitted property and casualty insurance company that's been A-rated by A.M. Best. As an emplo
• Prepare, develop and issue policy contracts, amendments and related forms as needed for complex product structures, in accordance with company policy and state regulations. • Document and maintain policy issuance process and state availability guidelines for assigned products. • Assist in policy automation efforts, including user acceptance testing of forms and benefit features. • Assist in maintaining current forms library and publishing updates for both internal and external use. • Maintain fulfillment status and regular reporting of fulfillment activity. • Complete fulfillment requests timely and accurately, within established timeframes. • Respond timely to customer requests and where applicable, leverage technology to streamline the fulfillment process. • Collaborate with Underwriting, Claims, Legal, and Actuarial teams to deliver high-quality insurance products and respond timely to product inquiries. • Analyze marketing/advertisements for compliance and problematic language. • Draft and file policy forms reflecting underwriting intent and consistent with regulatory requirements. • Develop issue instructions and ensure that the approved product is operationalized. • Establish and maintain strong relationships with internal business units and external partners. • Perform other related duties as assigned by the manager.
• Serve as primary contact for day-to-day IT requests • Install, configure, and support employee hardware, software, and accounts • Work with remote employees, vendors, and contractors • Procure and provision hardware, manage asset inventory • Assist with evidence collection and control testing for compliance obligations • Maintain accurate, audit-ready records • Occasionally support off-hours maintenance windows
Revenue Cycle Compliance Analyst
Adventist HealthLed by CEO Scott Reiner and President Bill Wing, Adventist Health is a faith-based, nonprofit healthcare system servicing western regions of the United States.
Role Description Assists with maintaining the system by keeping National Provider Identifiers (NPIs) for facilities and providers, and coder lists up to date. Provides education and assistance to system users, including but not limited to MDaudit analytics and audit set up. Onboards new users. Helps with the creation of Liveaboards, custom audit worksheets, and creating Ad Hoc reports. Performs analytic functions to support revcycle leadership to improve visibility into rev cycle compliance and performance. Ensures compliance with all revenue cycle regulatory requirements. Qualifications - Associate’s degree or equivalent combination of education/related experience: Required - Bachelor's Degree or equivalent combination of education/related experience: Preferred - Three years’ relevant revenue cycle experience: Required - Experience with MDaudit: Preferred - Familiarity with billing and coding: Preferred Requirements - One or more of the following: AHIMA: RHIT, RHIA, CCS, CCS-P, AAPC: CPC HCCA: CHC: Required Essential Functions - Ensures that MDaudit is ingesting all the market and provider billing and remit data. - Ensures that all facilities and providers are mapped in MDaudit. - Assists in assigning access to MDaudit to appropriate staff with the appropriate roles and assists users in how to access/use MDaudit. - Orients to the LEARN site. - Assists with payer audit workflow by setting up audits and loading ADRs. - Tracks, trends, and performs regular analysis of system compliance risks utilizing the key performance indicator (KPI) metrics in MDaudit. - Curates and maintains MDaudit Liveboards for each market. - Provides assistance with AdHoc reporting. - Stays current with government rules and regulations to ensure that MDaudit is kept up to date. - Performs other job-related duties as assigned. Organizational Requirements - Adventist Health is committed to the safety and wellbeing of our associates and patients. Therefore, we require that all associates receive all required vaccinations as a condition of employment and annually thereafter, where applicable. Medical and religious exemptions may apply. - Adventist Health participates in E-Verify. Visit https://adventisthealth.org/careers/everify/ for more information about E-Verify. By choosing to apply, you acknowledge that you have accessed and read the E-Verify Participation and Right to Work notices and understand the contents therein.




