Associate Manager CMC Regulatory Affairs

Dublin - Ireland

Monthly Salary: Not Disclosed

Posted on: 14 hours ago

Vacancies: 1 Vacancy

Job Summary

The Associate Manager CMC Regulatory Submissions Compliance supports the management of Clinical Trial Application (CTA) pre-submission review processes within CMC Regulatory this role you will coordinate and review documentation planned for submission to global health authorities ensuring consistency across CTAs and adherence to country-specific requirements.

A Typical Day

Contribute to and coordinate the CTA pre-submission review process to ensure consistent CMC information across global submissions and prevent clinical lot release issues.
Support regulatory release and QP certification by helping generate regulatory submission forms and related documentation.
Participate in cross-functional meetings to identify and resolve CMC regulatory issues in clinical trial submission documents.
Facilitate timely communication between IOPS and global development stakeholders.
Represent CMC Regulatory Affairs in meetings with CROs to ensure submission requirements are met; provide consistent metrics and feedback on CTA processes and procedures.
Help develop procedures and systems to enhance tracking of global regulatory submission packages and approval status.
Keep management and stakeholders informed of assessments strategies risks and project status.
Contribute to training programs and knowledge-sharing across teams.

This Role Might Be for You If You Have

Ability to build collaboration and teamwork across cross-functional teams.
Comfort working in ambiguity and delivering results with minimal direction.
A track record of positive relationship-building internally and externally.
Strong communication and negotiation skills.
Openness to change and a continuous improvement mindset.
Understanding of quality principles in a regulated manufacturing environment.

To be considered for this role

BS/BA in Chemistry Biology or a related field (advanced degree preferred). 5 years of experience in biopharmaceutical manufacturing or a related industry including regulatory or compliance activities. Strong compliance background preferred; program management experience is a plus.

Does this sound like you Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits which vary by the U.S. benefits may include health and wellness programs (including medical dental vision life and disability insurance) fitness centers 401(k) company match family support benefits equity awards annual bonuses paid time off and paid leaves (e.g. military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US please visit For other countries specific benefits please speak to your recruiter.
Please be advised that at Regeneron we believe we are most successful and work best when we are together. For that reason many of Regenerons roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regenerons on-site policy and expectations for your role and your location.

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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment unless the accommodation would impose undue hardship on the operation of the Companys business.

For roles in which the hired candidate will be working in the U.S. the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S Japan or Canada please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity right to work educational qualifications etc.

Required Experience:

Manager

A Typical Day

Contribute to and coordinate the CTA pre-submission review process to ensure consistent CMC information across global submissions and prevent clinical lot release issues.
Support regulatory release and QP certification by helping generate regulatory submission forms and related documentation.
Participate in cross-functional meetings to identify and resolve CMC regulatory issues in clinical trial submission documents.
Facilitate timely communication between IOPS and global development stakeholders.
Represent CMC Regulatory Affairs in meetings with CROs to ensure submission requirements are met; provide consistent metrics and feedback on CTA processes and procedures.
Help develop procedures and systems to enhance tracking of global regulatory submission packages and approval status.
Keep management and stakeholders informed of assessments strategies risks and project status.
Contribute to training programs and knowledge-sharing across teams.

This Role Might Be for You If You Have