Sr. Regulatory Associate

Job description

Ability to interpret, apply, and implement regulations and guidance. Share knowledge and experience with peers and cross functional team. Solid knowledge of Regulatory Agency organizations. Applies gained knowledge and experience to increasingly complex regulatory issues. Shares knowledge and experience with peers. Attend trade association/Regulatory Agency meetings and represent interests with key government agencies while remaining competitive. Assess the impact to the implementation of required company compliance with all regulations, laws and industry policies. Proactively manages and communicates issues, scopes, progress and risks throughout the project lifecycle ensuring key stakeholders are informed. Understands stakeholders timelines and objectives. Develop and communicate submission strategies to the cross-functional project team, including strategies required for integration of any merger, acquisition, or 3rd party license. Oversee the preparation, review/approval, and dispatch of the regulatory submission. Responsible for coordinating responses to Regulatory agency questions. Apply Microsoft Office programs and Systems relevant to area of responsibility to deliver against project strategy. Utilize online resources and programs to navigate key external agency and trade association web sites. Responsible for authoring and reviewing multiple and more complex departmental SOP/work practices Regards, Indu Clinical Recruiter 732-844-8725 indu @irionline.com IRI believes in commitment, Integrity and strategic workforce solutions. Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow. We’ve stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity. Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients’ success.