Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs, Worldwide Regulatory Affairs
4 Year Degree
We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA.
Who are we?
We Are PRA.
We are 16,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.
Who are you?
You are a leader that isn’t afraid to delegate, but also isn’t afraid to get your hands dirty. You look for new and innovative ways to problem solve. You are the ultimate planner and coordinator and are an excellent communicator. You have a serious passion for labeling. You never settle for what is, but are always pushing clinical development forward to what it could be. You motivate others to do the same. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.
Still here? Good. Because if this is you, we’d really like to meet you.
The Senior Regulatory Labeling Manager will be accountable for providing labeling support to the Global Regulatory Affairs portfolio.
What you will be doing:
An exciting position within PRA, providing labeling expertise to multiple clients.
Uses experience and knowledge of regulatory requirements to create and update labeling and labeling documentation for an assigned group of developmental and/or commercial pharmaceutical products, e.g., drugs, devices, and combination products, to optimize patient safety and efficacy and to minimize product liability risk. Works internally with clinical, quality and other functional areas, global and local regulatory affairs teams, supply chain and client preferred vendors and with external regulatory agencies to ensure timely regulatory and quality compliance and to support business objectives.
Generation of target product label
Generation of USPI for new product
Generation of SmPC for new product
Generation of initial cCDS
Global Labeling Strategy:
Provides regulatory expertise to drug development teams on the development and submission of labeling components for regulatory agency approval. Controls the consistency of labeling through review of content across the product family.
Identifies areas of potential non-compliance and supports investigations as needed. Escalates issues pertaining to implementation of core labeling content (Company Core Data Sheet (CCDS, Reference, or Master labels) into product labeling to ensure compliance to regulations and standard processes. Identifies potential non-compliance and supports investigations as needed.
Leads and facilitates the global/regional labeling working groups to support the development of core and major regional labeling.
Provides regulatory expertise and guidance for the development and submission of US labeling components. Controls the consistency of US labeling content through alignment with the core documents across product families and with all applicable best practices.
Creates/manages FDA-required Structured Product Labeling (SPL) documents, e.g., Labeling, Bulk Drug Listing, Establishment Registration, Blanket No Change Certifications.
Creates and provides lifecycle management for Prescribing Information, Patient Labeling or packaging artwork (layout, mock-ups, production artwork). Provides regulatory review and acts as text approver through alignment between approved content and artwork.
What do you need to have?
Education: Bachelor’s degree in relevant field of study or equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated
Bachelor’s degree in relevant field of study
At least 8-10 years of relevant experience or equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above.
Advanced knowledge of the scientific principles of the drug development process
Advanced, broad knowledge of regulations pertaining to drug product labeling
Excellent oral and written communication skills
Excellent project management skills
Excellent critical thinking skills
Excellent attention to detail
Potential travel - 10% for client meetings
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
2 openings. Telecommuting is allowed.
Internal Number: 2019-52683
About PRA Health Sciences
The story of PRA Health Sciences would naturally talk about how we’ve become one of the world’s largest CROs. It would talk about our innovation and growth and would speak to our operational efficiencies and transparency. It would highlight our expertise and customization. And it would touch on the incredible differences we’ve made, over our more than 30 years, in helping to bring to market everything from niche treatments and therapies to blockbuster drugs.
More than anything else, our story would be about people. Not only our over 16,000 + employees operating in more than 80 countries, though they’d certainly be a big part of it, but also the people that inspire them. The heroes of any PRA Health Sciences story are the clients we serve and the people whose lives we help improve, all over the world. And our story has only just begun.