Randstad Regulatory in Round Lake, Illinois
location:Round Lake, IL
salary:$55 - $60.15 per hour
date posted:Friday, June 22, 2018
Job Title: Pharmaceutical RA Manager
This position on the Regulatory team is accountable for the relationship with the US Food and Drug Administration, along with other relevant regulatory bodies. It is responsible for the local execution of Company's regulatory initiatives in line with business goals.
Responsible for defining regulatory strategies and submissions in support of new and existing marketing authorizations for products for one or more business units/countries.
Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations
Represent or lead the RA function on assigned cross-functional project teams
Monitor applicable regulatory requirements; assure compliance with Company and external standards
Establish appropriate communication within RA and other functions primarily at project level
Perform gap analysis and propose solutions
Develop and document sound regulatory decisions and justifications
Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
May provide direct supervision of individuals
May review promotional material or SOPs for compliance with regulations
Bachelor's degree or country equivalent in related scientific discipline with a minimum of 5 years regulatory experience in RA or related field, including managing people or projects.
Higher degree/PhD will be an advantage.
Technical skills: Documentum, SharePoint, Word, Excel, PowerPoint, Outlook (all other programs they will use, they can learn.)
Experience with US Drug Submissions (NOT MEDICAL DEVICE)
Previous leadership experience in a similar role.
Change Control in US Drug Products including assessment, analysis, etc.
Submission to FDA including prior approval, Changes Being Efficient (CBE)
Creating annual reports.
Sound basis of Regulatory knowledge
Ability to manage complex projects and timelines in a matrix team environment
Strong oral and written communication and presentation skills
Demonstrated interpersonal skills including strong negotiation skills
Ability to independently identify compliance risks and escalate when necessary
Ability to lead and coach others
Medical, Dental, and Vision Insurance
401K Plan with Company Match
Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.