What are the responsibilities and job description for the Associate Director CMC Regulatory Affairs - Quality Compliance position at BioSpace?
Build Our Future Together
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director, Quality Compliance, CMC Regulatory Affairs to join our CMC Regulatory Affairs team, supporting our manufacturing and supply business area in an onsite work model. In this role, you will provide strategic quality compliance leadership, guide regulatory impact assessments, and strengthen organizational alignment across quality and regulatory activities while collaborating with CMC Regulatory Affairs strategy teams, Quality Compliance colleagues, and global manufacturing and supply partners. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & Where
Location: Rensselaer
Work model: Onsite
Discover Your Role
Support management of the Quality Compliance group.
Provide leadership across the broader CMC Regulatory Affairs organization.
Champion consistent regulatory impact assessments and regulatory positions.
Assessing changes and deviations within Operation's Quality Management System (QMS).
Drive and support Corrective and Preventive Action plan ownership and closure.
Represent Quality Compliance at regulatory, infrastructure, and cross-functional meetings.
Lead process improvements, performance monitoring, and inspection readiness initiatives.
You build alignment across teams and translate complex issues into clear decisions.
This Role Requires
Bachelors degree in chemistry, biology, or a related discipline.
10 years of experience in the biotechnology or pharmaceutical industry.
Minimum 5 years of experience in CMC Regulatory Affairs or Quality.
Significant experience conducting regulatory impact assessments and utilizing Quality Management Systems (QMS)
CMC regulatory experience combined with Quality Management System experience is an advantage.
Experience managing direct reports and leading teams.
Ability to analyze complex information and communicate clear recommendations.
Experience presenting complex regulatory or quality compliance matters to stakeholders.
Ability to collaborate across cross-functional teams and build positive relationships.
Ability to work effectively in ambiguous environments with minimal direction.
Openness to change and a continuous process improvement mindset.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way!
We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$147,800.00 - $241,200.00
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director, Quality Compliance, CMC Regulatory Affairs to join our CMC Regulatory Affairs team, supporting our manufacturing and supply business area in an onsite work model. In this role, you will provide strategic quality compliance leadership, guide regulatory impact assessments, and strengthen organizational alignment across quality and regulatory activities while collaborating with CMC Regulatory Affairs strategy teams, Quality Compliance colleagues, and global manufacturing and supply partners. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & Where
Location: Rensselaer
Work model: Onsite
Discover Your Role
Support management of the Quality Compliance group.
Provide leadership across the broader CMC Regulatory Affairs organization.
Champion consistent regulatory impact assessments and regulatory positions.
Assessing changes and deviations within Operation's Quality Management System (QMS).
Drive and support Corrective and Preventive Action plan ownership and closure.
Represent Quality Compliance at regulatory, infrastructure, and cross-functional meetings.
Lead process improvements, performance monitoring, and inspection readiness initiatives.
You build alignment across teams and translate complex issues into clear decisions.
This Role Requires
Bachelors degree in chemistry, biology, or a related discipline.
10 years of experience in the biotechnology or pharmaceutical industry.
Minimum 5 years of experience in CMC Regulatory Affairs or Quality.
Significant experience conducting regulatory impact assessments and utilizing Quality Management Systems (QMS)
CMC regulatory experience combined with Quality Management System experience is an advantage.
Experience managing direct reports and leading teams.
Ability to analyze complex information and communicate clear recommendations.
Experience presenting complex regulatory or quality compliance matters to stakeholders.
Ability to collaborate across cross-functional teams and build positive relationships.
Ability to work effectively in ambiguous environments with minimal direction.
Openness to change and a continuous process improvement mindset.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way!
We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$147,800.00 - $241,200.00
Salary : $147,800 - $241,200