Requirements
Bachelor Degree in scientific discipline required or equivalent work experience.
5 or more years of Regulatory experience or related field. RAC certification preferred.
Cross functional interaction experience, coordinating activities, driving projects and initiatives to completion, and working to align communications with other departments is required.
Project leadership or supervisory experience is preferred.
Strong organizational skills, strong attention to detail, ability to problem solve and to work well with others and cross-functionally.
Excellent written and oral communication skills.
Use of software system to manage change controls.
Strong background using Microsoft Office tools and Adobe Acrobat.
Travel Time Required - up to 10% (May vary depending on region/site).
Working Conditions:
Standard office environment.
Willingness to work in a team-based environment.
Close attention to detail required.
May be required to sit or stand for long periods of 8+ hours a day while performing duties.
The position deals with many deadlines. Due to the short turnaround time of deadlines and limited time, overtime, weekend work and holiday work is sometimes required.
Essential Functions
Authoring, organization, and preparation of electronic (eCTD) regulatory filings; also includes peer review of filings.
Understand, identify potential regulatory risks and recommend strategies based on current FDA/health authority requirements.
Manage multiple priorities.
Attend necessary trainings and seminars to keep abreast of new and/or changes in the Regulatory profession.
Process, interpret and provide recommendations for complex, unusual issues.
Critically review documentation for regulatory submissions and provide input for necessary revisions.
Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA,EU,HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
Summary of Position
The Senior Regulatory Affairs Specialist's responsibilities encompass the support of US FDA applications (NDAs, ANDAs, DMFs) and support of Regulatory activities including but not limited to:
Plan/author/compile/submit statutory reports in eCTD format for marketed products per FDA requirements
Review, assess CMC regulatory impact and provide regulatory strategy for post-approval changes proposed at the manufacturing site
Where appropriate, act as the CMC regulatory lead to cross-functional teams and other personnel on health authority requirements and preparation of information/technical data needed for support of post-approval changes
Author/compile/submit post-approval change supplements
Author/review updates to marketed product labeling
Maintain regulatory knowledge of current guidelines and regulations
Maintain current regulatory databases and produce various reports as needed
Utilize and support electronic document management system
Provides mentorship for entry-level and intermediate-level regulatory associates
Get to know Advanced Resources.
We are a group of hard working, dedicated professionals who are committed to providing quality staffing solutions to our clients and creating opportunities for our candidates. We have different interests, like cooking, baseball, traveling, golf, volunteering, teaching and even an appreciation for 80s music – just like you, we are multi-dimensional. Regardless of where our personal passions lie, one thing is universal, our desire to create solutions and to find a great career fit for you!
Our company goal.
Since 2002, many of the nation's most respected Fortune 500 companies have turned to us for innovative, cost-effective workforce solutions. Our goal is to be a strategic business partner delivering staff augmentation resources, direct hires, contract to hire and training solutions across multiple verticals throughout the country. Resources you want, when you need them, from people you trust and want to work with.