• Provide compliance guidance from product concept through post-launch oversight • Partner with Product, Legal, and Risk teams to evaluate regulatory requirements for new or modified products • Identify and coordinate updates to ADV filings, disclosures, and policies tied to product changes • Review and advise on product marketing materials to ensure accuracy and compliance under SEC, FINRA, and DOL rules • Collaborate with business partners to balance innovation with regulatory expectations • Participate in governance forums, committees, and working groups on product development and communications • Track regulatory developments and advise leadership on potential product impacts • Maintain and enhance internal procedures supporting Empower’s product compliance framework • Prepare summaries and reports for senior leadership on compliance activities and emerging risks • Partner with cross-functional stakeholders to ensure product-related risks are identified, documented, and mitigated

• support regulatory strategy implementation for development programs • lead and prepare regulatory submissions (authoring, timeline planning, etc.) • assist in developing and implementing global regulatory strategies • establish and maintain department regulatory processes • develop collaborative and productive partnerships internally, as well as externally with contract research organizations, electronic publishing, and other vendors as required • actively participate as a member of Regulatory Affairs teams and on cross-functional product development teams as needed • contribute to developing and implementing regulatory strategies for global submissions from early research and development (R&D) through commercialization • lead the compilation, review and/or filing of INDs, CTAs, briefing documents and maintenance of development and approved applications • coordinate and contribute to the authoring of submission documents such as DSURs, annual reports, and amendments as needed • develop and manage project timelines for regulatory submissions • maintain effective interactions with all contributors and Regulatory Affairs management, to ensure timely delivery of documents for regulatory submission • provide regulatory assistance and review of clinical study documentation, including review of clinical protocols, informed consent documents, clinical study recruitment materials, and essential document packages • track submissions, correspondence, and commitments with health authorities • provide guidance to project teams to ensure regulatory documentation is complete, accurate, of high quality and electronically functional • provide regulatory intelligence and research to the team as needed • write and/or maintain standard operating procedures, department working practices, templates and style guides, as appropriate • lead, direct, manage, coach/mentor, and evaluate direct reports

• Collaborates with client’s project team members and key decision makers to gain a complete understanding of a product and transforms that knowledge into an actionable regulatory strategy. • Responsible for implementing the strategy, which often entails engaging regulatory authorities, authoring submissions, and interacting with the authorities throughout the regulatory review. • Deliver full-service oversight and consultation to clients by providing strategic regulatory considerations and paths to market, combined with a commitment to getting products approved in various regions. • Collaborate with clients’ project team members and key decision makers to gain a complete understanding of the product and goals and transform that knowledge to a strategy that balances risk with potential regulatory outcomes of proposed paths in a way that clients can understand and apply in decision making. • Identify, propose, plan, and direct regulatory projects, transforming the regulatory strategy into executable project plans that achieve desired results and timelines. • Serve as a trusted intermediary with health authorities to build and maintain a positive relationship on behalf of clients. • Negotiate with health authorities during the development and review processes to ensure productive submission process.

• Participate in IS disaster response/crisis management activities in compliance with the IS Disaster Recovery (DR) policy • Help provide and coordinate disaster preparedness training with respect to the organization’s information technologies • Support, implement and maintain policies, procedures, and programs for ensuring the integrity and recoverability of company data, databases, information systems, and technology • Maintain contingency and DR plans for central and distributed systems and networks to maintain operations during downtime and/or major disasters • Identify and make recommendations regarding critical points of failure • Exercise test plans with various operational and support groups in IS