Manager Product Compliance (Retains/Returns Complaints)

The Post Marketing Operations department is hiring! The Associate Manager Product Compliance (Retains/Returns Complaints) position leads a team responsible for providing quality assurance oversight of site compliance focused primarily on the retention sample program and external handling of product complaint samples.  They will ensure compliance with general day-to-day QA support regarding documentation and SOPs and conduct review of internal and external records. This position will also participate in cross-functional team investigations /efforts with other functions such as Manufacturing (Internal and External), Quality Control, Quality Assurance, Global Patient Safety in accordance with mandated regulatory requirements and site expectations and acts as an advisor to these groups of how to maintain and improve compliance. They will become involved as required to meet schedules or resolve problems.

As an Manager Product Compliance (Retains/Returns Complaints), a typical day might include the following:

• Manage tasks specific to complaints operations including sample returns
• Manages Commercial Retention sample and Investigational retain program
• Manage multiple lab sites for compliant sample returns and retain examination
• Prepares status reports for management
• As appropriate, trains staff and user departments in Product Complaint items
• Reviews/Approves product complaints files
• Correspond with personnel and contractors across sites and externally (partners, vendors, Tarrytown)
• Ensure Inspection readiness for complaint and retain related items
• Participate as SME for area during inspections/audits as needed
• Plan, schedule, and guide team to ensure compliance
• Identify gaps in systems and develop feasible plans for corrections
• Facilitating continuous improvement initiatives specific to function.
• Ensuring appropriate training programs are completed related to function
• Apply knowledge of regulatory requirements to identify reportable events when received and provide support of decisions

This role might be for you if:

• You have strong interpersonal, cross- cultural, communication, negotiation, technical, and problem-solving skills.
• You exhibit a degree of ingenuity, creativity and resourcefulness in a sometimes evolving and ambiguous environment.
• You understand and listen to team members and partners while encouraging a productive team environment to one common project objective.
• You are committed to proactive resolution of project related issues with tact, subtlety and composure.
• You are able to provide clear direction to others in ambiguous situations and environments.
• You exhibit confidence and a high emotional IQ.
• You possess knowledge of industry practices and regulations (e.g. GxP, ISO, ICH, etc.)
• Experience handling third party vendors and partner relationships
• You apply technical expertise (in your area) and may contribute to the development of new concepts, techniques and standards.
• You are proficient in advanced techniques with relevant software: MS Project, Excel, PowerPoint, Word, etc. in addition to experience working within shared work environments
• Experience with combination devices, visual examinations, and product sample handling

In order to be considered for this position, you must hold a BS/BA in scientific subject area or related field and

• Manager: 7+ years of relevant work experience in pharmaceutical or related industry
• Senior Manager: 8+ years of relevant work experience in pharmaceutical or related industry
• Prior experience with Regulatory Reporting Guidelines in desired

#REGNQA #LI-Hybrid

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)

$101,800.00 - $194,200.00