Title: Regulatory Affairs Specialist, Global Regulatory Affairs
Location: Edison, NJ, New York, NY, Raleigh, NC
If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE AND REGION within the subject line.
This role supports the Associate Director, Regulatory Affairs. The role holder will support various aspects of Global Regulatory Affairs, including, but not limited to: planning, preparing and delivery of high quality electronic documents for regulatory submissions of investigational and marketed products worldwide. This position requires expertise on US, EU and ICH standards for regulatory submissions, confirming that submission documents meet submission requirements among other related tasks as they arise.
Support the Associate Director, Global Regulatory Affairs with the following;
––Developing submission content plans and submission timelines,
––Managing multiple regulatory submissions,
––Leading and driving cross-functional teams focused on the execution of regulatory submissions including anticipating regulatory obstacles, identifying emerging issues and proactively developing solutions,
––Leading and facilitating submission planning meetings to ensure clear communication of the project plan, action items, risks and decisions to the team,
––Formatting documents, building the electronic submission and reviewing dossiers to ensure submissions are of the highest quality and delivered on time,
––Working directly with the publishing and transmittal third party vendor to ensure an accurate and quality assembly and submission of dossiers,
––Perform other duties as assigned.
Thorough knowledge and understanding of Health Authority regulations, guidance documents and the drug development process. Demonstrates an expert understanding of document preparation process and role of each contributing discipline. Demonstrate ability to work cross-functionally to develop project plans, proactively identify risks, develop risk mitigation strategies, communicate project team decisions and project status. Proficiency with Microsoft Office and Adobe Acrobat is required. Ability to work independently and collaboratively in a fast-paced environment with internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. Independent, ability to multitask, self-motivated, methodical, well organized, highly detailed oriented, works effectively under pressure. Excellent written and verbal communication skills.
BS degree in pharmaceutical sciences, biochemistry, biology, public health, or a similar field. A minimum of 2 year industry experience in Regulatory or Project Management