We are currently looking to fill an Associate Director, Product Compliance (Complaints) position. This position directs product compliance associated with commercial and clinical investigational products in accordance with mandated regulatory requirements and site expectations. This work includes processing of incoming events as well as coordinating and oversight of potential product recalls or recoveries from the market place and retain management responsibilities.
In this role, a typical day might include the following:
Lead and develop the group responsible for handling product complaints.
Interacts with customers through senior management during complaint process.
Collaborate closely with the Pharmacovigilance group to correlate Adverse Events.
Interpret compliance requirements for incorporation into company systems and procedures.
Participate in regulatory and customer audits.
Actively participate in company continuous improvement initiatives.
Monitor trending to maintain flawless compliance and develop feasible plans for correction and preventative actions associated with findings.
Involvement with investigations and/or product complaints with focus on categorization and risk classification.
Lead team responsible for investigation support from partners and contract manufacturers.
Lead efforts to acquire and analyze complaint return samples.
Oversight of the Drug Product, Drug Substance and Formulated Drug Substance retains.
This role might be for you if you:
Have strong leadership and project management skills
Are experienced in pharmaceutical or medical device complaint processing
Thrive in a quality focused environment
Are able to mentor and encourage others
Possess a positive, proactive approach to drive projects/tasks to completion
To be considered for this role you must hold a BA/BS degree in a scientific subject area or related field with 10+ years of relevant work experience in the pharmaceutical or related industry, and experience with complaint handling practices. Equivalent combination of education and experience may be considered.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)