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 17,000+ 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 help get life-saving drugs into the hands of 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
We are looking for US Regulatory subject matter experts and FDA liaisons for assigned development projects that will provide expert regulatory strategic consulting to sponsor client companies and to PRA stakeholders.
What you will be doing:
Support PDR Program Manager in his/ her responsibilities and assist the PDR Program Manager to accomplish his/her tasks in meeting deadlines to achieve the projects, teams and departmental goals
Prepare regulatory submissions in collaboration with the other disciplines in PDR
Establishes effective working relationships internally and externally with regulatory authorities.
Documents meetings, teleconferences and other interactions/communications with regulatory authorities.
Additional regulatory- and project-related support activities/Services as requested by the client's project lead(s)/team(s).
Ensures compliance with SOPs and national regulations.
Participates in and/or otherwise supports development and implementation of new or updated PDR and/or Regulatory Affairs-specific systems, processes, Standard/Department Operating Procedures (SOPs/DOPs) or other relevant tools as appropriate
Completes other routine and ad hoc analysis and reporting. Responsible to keep all internal customers, partners and stakeholders abreast of progress and interim updates. Does so by following prescribed departmental procedures, practices and protocols and by using standardized reporting and communications tools/templates and other resources
Participates in other special projects, as and when assigned, or otherwise requested
Remain, at all times, fully abreast and apprised of evolving internal and external needs, processes and requirements as appropriate. Expected to share best practices within the department and cross functionally, identify and communicate opportunities for departmental enhancements and efficiencies
Consistently complies with all governing laws, regulations, the client's SOPs and other guidelines
What you need to have
Graduate (Bachelors) Degree required (life sciences disciplines strongly preferred)
Average of 3 or more years' relevant clinical experience in regulatory affairs (US, EU, ROW); including extensive knowledge of clinical drug development, submission requirements and Health Authority interactions.
Clinical Regulatory Affairs experience (specifically experience providing advice on drug development, a strategist).
Knowledge of GxP, ICH, and other regulatory guidelines.
Knowledge of the drug development process and how other functions contribute.
Fully competent in teamwork/collaboration, achieving results, regulatory knowledge, operational excellence and organized.
Level of direct therapeutic area experience is role dependent.
Strong regulatory program management, leadership, teamwork, and communication skills.
Strong verbal and writing skills; proficient in MS Office apps.
EXAMPLES OF WORK: Support IND/NDA/BLA maintenance, support filings (INDs, BLAs, NDAs), support FDA meetings, support post marketing activities, representing regulatory at study team meetings, and coordinate answers to regulatory questions.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
PRA Health Sciences