Posted on 15th May 2019
Senior Regulatory Affairs Specialist – Ad/Promo & Compliance
Curium was formed in 2017 through the union of IBA Molecular and Mallinckrodt Nuclear Medicine LLC. Curium is a world-class nuclear medicine solutions provider with over 100 years of combined industry experience. We are proud to service over 14 million patients worldwide each year and strive to provide best-in-class quality products and exceptional, reliable service.
Our diverse group of industry experts is unified under one strong and singular focus – to develop, manufacture and supply SPECT, PET and therapeutic radiopharmaceuticals to customers around the globe. In fact, we have over 6,000 customers in over 70 countries world-wide.
At Curium, every single dose counts in helping doctors and patients diagnose and treat disease. That means every single employee counts toward meeting this unified objective to help each patient live “Life Forward”. We have an amazing team that lives by our core values every single day – integrity, commitment and collaboration. Come grow with us!
Summary of Position
The Senior Regulatory Affairs Specialist responsibilities encompass the support of US FDA product registrations and support of Regulatory activities including but not limited to:
- Support growth of advertising and promotional material review department and company by improving processes for new product launches
- Prepare, submit, and maintain advertising and promotional material submissions per FDA requirements.
- Review advertising and promotional material and represent Regulatory at ad/promo review committee meetings.
- Review of product labeling as required.
- Review and assess current practices and dossiers for compliance to current FDA standards.
- Address regulatory compliance issues through a strategic cross-functional approach and project management.
- Develop regulatory strategies for complex situations involving multiple products.
- Maintain current regulatory knowledge by reviewing Heath Authority laws regulations, guidance, monitoring relevant compendium and attendance at regulatory seminars and meetings.
- Provide training and support to colleagues.
- Lead cross-functional team meetings as necessary.
- Provide project management support for regulatory projects and submissions.
- Participate in cross-functional core teams and create regulatory strategies independently.
- Manage multiple priorities.
- Organization and preparation of paper and electronic regulatory filings.
- Understand and recommend strategies based on current FDA requirements.
- Audit documentation and dossiers for regulatory compliance.
- Mentor less senior colleagues as well as provide training and support.
- Attend necessary trainings and seminars to keep abreast of new and/or changes in the Regulatory profession.
- Process, interpret and provide recommendations for complex and unusual issues.
- Utilize and support electronic document management system
- Maintain current knowledge of newly published FDA and Compendium to communicate to internal stake holders.
- Other regulatory projects as assigned.
- Bachelor Degree required. Degree in scientific field preferred.
- Five to eight years of Regulatory Affairs experience or related field.
- Advertising and Promotional Material Review experience preferred.
- Knowledge of FDA regulations and guidelines preferred.
- Strong organizational skills
- Strong attention to detail
- Ability to problem solve
- Ability to work well with others
- Ability to lead cross-functional meetings
- Team Oriented
- Excellent written and oral communication skills
- Project Management experience
- Strong background using Microsoft Office tools and Adobe Acrobat
- Standard office environment, coupled with approximately 25% time in clean room, radiopharmaceutical manufacturing, and laboratory environments.
- Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Equal Opportunity Employer
Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.