Manager Regulatory Information Management
Role details
Job location
Tech stack
Job description
Responsible for ensuring that regulatory information is properly managed across the lifecycle of products. This includes overseeing the data accuracy, consistency, and timeliness. Also working cross functionally to ensure the optimal flow of this accurate regulatory information can be utilised across Regeneron. Supports downstream regulatory submissions such as INDs, IND amendments, BLAs, BLA supplements, MAAs, MAA variations and/or CTAs in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). + Requires some guidance from direct manager + Functions as a contributor as needed + Provides support and backup to management as needed May have people management responsibility JOB DUTIES: List essential (6-10) to be performed. These are the most critical responsibilities + Management and oversight of RIM registration details, including build out of registration records, including master data and transactional data. + Drive ongoing RIM data quality, including: Data quality Monitoring and ensuring compliance and timely remediation. + Attention to detail and the ability to reinforce core RIM data rules and processes across the business. + Supports the archival of global regulatory Health Authority interactions, such as approval letters, meeting minutes and acknowledgement letters + Oversees the successful process to manage transfer of submissions to partners of Regeneron + Oversees the Archive of legacy Submissions and Correspondences + Gathers information for submission exchange with new/potential partners + Assists with reviewing and developing departmental procedural documents in accordance with Agency regulations and guidance + Assists with audit and inspection activities including retrieval of Regulatory information + Identifies and communicates regulatory system enhancement needs or technical issues + Assists with managing RIM knowledge objects + Identifies future needs for RIM and facilitates the process of maturing ideas into initiative proposals JOB REQUIREMENTS: List knowledge, skills, and abilities required to perform the job. List any preferred job requirements as well. Knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (e.g., FDA, EMA, ICH, eCTD, IDMP, etc.). Knowledge of pharmaceutical drug and device development process and scientific industry terminology. Experience with project management methodologies. Experience in Regulatory Information Management/Regulatory Affairs/Operations. Knowledge and practical experience in global submissions and principles of RIM technology. Experience managing technology projects (e.g. RIM, EDMS, tracking systems, etc.). Ability to lead, manage, and contribute to multiple ongoing projects simultaneously. Training or public speaking experience required. Knowledge of SDLC methodologies preferred. Ability to engage and influence a variety of stakeholders at all organizational levels, Responsible for ensuring that regulatory information is properly managed across the lifecycle of products. This includes overseeing the data accuracy, consistency, and timeliness. Also working cross functionally to ensure the optimal flow of this accurate regulatory information can be utilised across Regeneron.
Supports downstream regulatory submissions such as INDs, IND amendments, BLAs, BLA supplements, MAAs, MAA variations and/or CTAs in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
- Requires some guidance from direct manager
- Functions as a contributor as needed
- Provides support and backup to management as needed
May have people management responsibility
JOB DUTIES: List essential (6-10) to be performed. These are the most critical responsibilities
- Management and oversight of RIM registration details, including build out of registration records, including master data and transactional data.
- Drive ongoing RIM data quality, including: Data quality Monitoring and ensuring compliance and timely remediation.
- Attention to detail and the ability to reinforce core RIM data rules and processes across the business.
- Supports the archival of global regulatory Health Authority interactions, such as approval letters, meeting minutes and acknowledgement letters
- Oversees the successful process to manage transfer of submissions to partners of Regeneron
- Oversees the Archive of legacy Submissions and Correspondences
- Gathers information for submission exchange with new/potential partners
- Assists with reviewing and developing departmental procedural documents in accordance with Agency regulations and guidance
- Assists with audit and inspection activities including retrieval of Regulatory information
- Identifies and communicates regulatory system enhancement needs or technical issues
- Assists with managing RIM knowledge objects
- Identifies future needs for RIM and facilitates the process of maturing ideas into initiative proposals, Responsible for ensuring that regulatory information is properly managed across the lifecycle of products. This includes overseeing the data accuracy, consistency, and timeliness. Also working cross functionally to ensure the optimal flow of this accurate regulatory information can be utilised across Regeneron. Supports downstream regulatory submissions such as INDs, IND amendments, BLAs, BLA supplements, MAAs, MAA variations and/or CTAs in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). + Requires some guidance from direct manager + Functions as a contributor as needed + Provides support and backup to management as needed May have people management responsibility JOB DUTIES: List essential (6-10) to be performed. These are the most critical responsibilities + Management and oversight of RIM registration details, including build out of registration records, including master data and transactional data. + Drive ongoing RIM data quality, including: Data quality Monitoring and ensuring compliance and timely remediation. + Attention to detail and the ability to reinforce core RIM data rules and processes across the business. + Supports the archival of global regulatory Health Authority interactions, such as approval letters, meeting minutes and acknowledgement letters + Oversees the successful process to manage transfer of submissions to partners of Regeneron + Oversees the Archive of legacy Submissions and Correspondences + Gathers information for submission exchange with new/potential partners + Assists with reviewing and developing departmental procedural documents in accordance with Agency regulations and guidance + Assists with audit and inspection activities including retrieval of Regulatory information + Identifies and communicates regulatory system enhancement needs or technical issues + Assists with managing RIM knowledge objects
- Identifies future needs for RIM and facilitates the process of maturing ideas into initiative proposals JOB REQUIREMENTS: List knowledge, skills, and abilities required to perform the job. List any preferred job requirements as well. Knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (e.g., FDA, EMA, ICH, eCTD, IDMP, etc.). Knowledge of pharmaceutical drug and device development process and scientific industry terminology. Experience with project management methodologies. Experience in Regulatory Information Management/Regulatory Affairs/Operations. Knowledge and practical experience in global submissions and principles of RIM technology. Experience managing technology projects (e.g. RIM, EDMS, tracking systems, etc.). Ability to lead, manage, and contribute to multiple ongoing projects simultaneously. Training or public speaking experience required. Knowledge of SDLC methodologies preferred., Ability to engage and influence
Requirements
required. Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills. Working knowledge of RIM technology solutions (Veeva Vault preferred), eCTD and Non-eCTD publishing systems, submission validation and viewing tools, XML, Microsoft Office suite, and Adobe Acrobat are required. Possess courage, energy and drive, strong operating skills, strong personal and interpersonal skills, strong critical thinking, and strong strategic skills May be responsible for supervising staff. 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, Knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (e.g., FDA, EMA, ICH, eCTD, IDMP, etc.).
Knowledge of pharmaceutical drug and device development process and scientific industry terminology.
Experience with project management methodologies.
Experience in Regulatory Information Management/Regulatory Affairs/Operations.
Knowledge and practical experience in global submissions and principles of RIM technology.
Experience managing technology projects (e.g. RIM, EDMS, tracking systems, etc.).
Ability to lead, manage, and contribute to multiple ongoing projects simultaneously.
Training or public speaking experience required.
Knowledge of SDLC methodologies preferred.
Ability to engage and influence a variety of stakeholders at all organizational levels required.
Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills.
Working knowledge of RIM technology solutions (Veeva Vault preferred), eCTD and Non-eCTD publishing systems, submission validation and viewing tools, XML, Microsoft Office suite, and Adobe Acrobat are required.
Possess courage, energy and drive, strong operating skills, strong personal and interpersonal skills, strong critical thinking, and strong strategic skills, a variety of stakeholders at all organizational levels, required. Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills. Working knowledge of RIM technology solutions (Veeva Vault preferred), eCTD and Non-eCTD publishing systems, submission validation and viewing tools, XML, Microsoft Office suite, and Adobe Acrobat are required. Possess courage, energy and drive, strong operating skills, strong personal and interpersonal skills, strong critical thinking, and strong strategic skills May be responsible for supervising staff. 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
Benefits & conditions
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 Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's 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. seo.joblisting 0, 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., 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 Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's 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. Manager Regulatory Information Management United Kingdom GBR None None Uxbridge Regeneron Pharmaceuticals Manager Regulatory Information Management
