Sr. Regulatory Associate

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