What are the responsibilities and job description for the Associate Director, CMC Regulatory Affairs (Hematology/Oncology) position at BioSpace?
As an Associate Director you will lead the development and execution of global CMC regulatory strategies for the hematology and oncology portfolios. You will guide regulatory activities across development stages, mentor CMC Regulatory Affairs (RA) staff, supporting cross-functional and external partners, and serving as a key liaison in regulatory authority interactions.
For US locations Tarrytown,, NY this role is on-site 4 days in the office and 1 day from home. For Uxbridge, UK or Dublin, Ireland this role would be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position . If eligible, we can offer relocation benefits.
A Typical Day May Include The Following
Lead product development activities from a CMC regulatory standpoint with input from senior management.
Represent CMC RA at program meetings and independently provide regulatory interpretation, position, and covering clinical development, initial market applications, and approval/post-approval activities.
Identify program issues and develop appropriate regulatory strategies to mitigate risks to filings, independently find alternative solutions/work-arounds, and obtain consensus.
Critically review and provide meaningful and strategic input on regulatory filing documents (e.g., INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements) to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics.
Lead and facilitate interactions with global regulatory authorities (e.g., meetings, IR responses, inspections).
Perform final review and approval of the compliance activities of the portfolios to confirm regulatory impact and associated submission requirements for clinical and commercial regulatory filings in accordance with country-specific regulatory guidance documents;
Mentor colleagues in difficult compliance assessment discussions with SMEs or Senior Management; find opportunities for improvement of processes for compliance tasks.
Develop and create working instructions, SOPs, and/or templates to facilitate consistent and efficient practice across the CMC RA groups.
Identify gaps in the IOPS and global RA processes, bring up to higher management, and help to improve business efficiency.
Support establishing, managing, and maintaining a knowledge base of current and emerging regulatory requirements and guidelines in the CMC field.
Find opportunities to initiate operational changes and policy modifications.
Manage and coach team member(s).
This May Be For You If You
Have a strong grasp of CMC worldwide regulations and guidelines.
Have been successful in building collaboration and teamwork across cross-functional teams.
Can demonstrate a proven track record managing and mentoring people.
Demonstrated skill in managing multiple priorities.
To be considered a bachelors degree with a minimum of 10 years of pharmaceutical/biotech industry experience, including 5 years of relevant CMC experience. An advanced degree is preferred. Proven track record supporting small molecule drugs and/or biological products through development and approval is a distinct advantage. It is required to have a good understanding of current CMC worldwide regulations and guidelines. Experience in interacting with the US FDA and other regulatory authorities. Experience with device regulatory requirements and development processes for combination products 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 location. In 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 https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. 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 Company's 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.
Salary Range (annually)
$157,200.00 - $256,600.00
For US locations Tarrytown,, NY this role is on-site 4 days in the office and 1 day from home. For Uxbridge, UK or Dublin, Ireland this role would be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position . If eligible, we can offer relocation benefits.
A Typical Day May Include The Following
Lead product development activities from a CMC regulatory standpoint with input from senior management.
Represent CMC RA at program meetings and independently provide regulatory interpretation, position, and covering clinical development, initial market applications, and approval/post-approval activities.
Identify program issues and develop appropriate regulatory strategies to mitigate risks to filings, independently find alternative solutions/work-arounds, and obtain consensus.
Critically review and provide meaningful and strategic input on regulatory filing documents (e.g., INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements) to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics.
Lead and facilitate interactions with global regulatory authorities (e.g., meetings, IR responses, inspections).
Perform final review and approval of the compliance activities of the portfolios to confirm regulatory impact and associated submission requirements for clinical and commercial regulatory filings in accordance with country-specific regulatory guidance documents;
Mentor colleagues in difficult compliance assessment discussions with SMEs or Senior Management; find opportunities for improvement of processes for compliance tasks.
Develop and create working instructions, SOPs, and/or templates to facilitate consistent and efficient practice across the CMC RA groups.
Identify gaps in the IOPS and global RA processes, bring up to higher management, and help to improve business efficiency.
Support establishing, managing, and maintaining a knowledge base of current and emerging regulatory requirements and guidelines in the CMC field.
Find opportunities to initiate operational changes and policy modifications.
Manage and coach team member(s).
This May Be For You If You
Have a strong grasp of CMC worldwide regulations and guidelines.
Have been successful in building collaboration and teamwork across cross-functional teams.
Can demonstrate a proven track record managing and mentoring people.
Demonstrated skill in managing multiple priorities.
To be considered a bachelors degree with a minimum of 10 years of pharmaceutical/biotech industry experience, including 5 years of relevant CMC experience. An advanced degree is preferred. Proven track record supporting small molecule drugs and/or biological products through development and approval is a distinct advantage. It is required to have a good understanding of current CMC worldwide regulations and guidelines. Experience in interacting with the US FDA and other regulatory authorities. Experience with device regulatory requirements and development processes for combination products 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 location. In 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 https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. 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 Company's 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.
Salary Range (annually)
$157,200.00 - $256,600.00
Salary : $157,200 - $256,600