Senior Regulatory Affairs Program Manager (remote)
Location: Mounds View, Minnesota
Type: Full Time
Required Education: 4 Year Degree
Worldwide Regulatory Affairs
4 Year Degree
Telecommuting is allowed.
Internal Number: 22000D9V
SENIOR REGULATORY AFFAIRS PROGRAM MANAGER
This position is an exciting and new opportunity that is currently part of Medtronic and will move to a to-be-named company we are calling “NewCo”. NewCo will be an independent company with equal partners, Medtronic & DaVita. It will be established in calendar 2023 as a new company (NewCo) formed from Medtronic’s Renal Care Solutions Operating Unit focused on providing innovative technologies to support kidney care patients. While you will start your employment with Medtronic, upon establishment of NewCo your employment will transfer to NewCo and you will no longer be employed by Medtronic.
NewCo is uniquely poised to transform renal care and dialysis, building on Medtronic’s innovation and technology pipeline. The business will have the singular focus, financial commitment, deep domain expertise, and global footprint needed to accelerate the development and commercialization of affordable and scalable life-saving renal care technologies — particularly our transformative home dialysis platform technologies.
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident —we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
Careers That Change Lives
The Senior Regulatory Affairs Program Manager will develop and execute regulatory strategies and operation for pharmaceutical product in development to support clinical trial applications and marketing approvals, globally. Additional responsibilities include responsibility for life cycle management, including maintaining compliance with applicable regulatory requirements as well as leading and implementing departmental process improvements, overseeing compliance matters, and regulatory intelligence.
A Day In The Life
Provides regulatory and scientific leadership to the overall development team to ensure that the development plan provides for optimal scientific positioning and the highest regulatory probability of success.
Develops regulatory strategies, identifies submission deliverables, works closely with the cross functional team to develop regulatory timelines and collaborates closely with all functional areas to obtain on time delivery of information.
Plans, authors, and reviews submissions to regulatory authorities including FDA, EMA and other global regulatory authorities to support the conduct of clinical trials and approval of marketing applications (including but not limited to Investigational New Drug (IND), Clinical Trial Authorization (CTA), New Drug Application (NDA), Abbreviated New Drug Applications (ANDA), Marketing Authorization Application (MAA), and Drug Master Files (DMF), all in Common Technical Document (CTD) format.
Interacts and negotiates effectively with regulatory authorities to resolve regulatory issues that may occur during pre-approval and post approval reviews.
Prepares and leads meetings with the regulatory authorities, as required.
Secures necessary wholesale distributor licenses including third party logistics providers (3PL) and associated reporting of licensure to regulatory authorities.
Manages electronic domestic and foreign establishments and listings (eDRLs).
Manages product lifecycle activities and post market reporting activities.
Maintains correspondences including controlled correspondence and other records of interaction with regulatory authorities.
Serves as the primary point of contact for assigned programs with Regulatory Authorities.
Provides regulatory guidance and/or training to global teams including research and development (R&D), quality, operations, supply chain, and marketing early in the development phase on the interpretation/application of regulatory requirements.
Review scientific information and design documentation to ensure the data is complete, sound, logical, and supports the program goals. Must be able to work with authors to ensure supporting information is high quality, clearly and logically written, to ensure it is submission ready.
Provide guidance on labeling requirements to ensure compliance to regulations, review and approve labeling as well as promotional and advertising collateral.
Participate in Risk Evaluation and Mitigation Strategy (REMS) drug safety program, as required.
Supports post approval compliance activities as needed (Annual Reports, CBE, CBE-30, and Prior Approval Supplements)
Participate in audits, including, but not limited to, GMP (21 CFR Parts 210/211, 21 CRF Part 11) Quality Systems, REMS, pre-approval inspections.
Performs regulatory activities for adverse event reporting and field alerts.
Prepares and revises internal procedures for continuous improvement.
Provides leadership, mentorship, of less experienced staff and maintains a positive work environment.
Supports business development activities, serving as a regulatory expert as part of cross-functional diligence teams to assess external.
Must Have; Minimum Requirements
Bachelor’s Degree with 7+ years of Program Manager experience in regulatory affairs supporting new drug, generics and combination products or another regulated industry in addition to experience with regulatory strategy and submissions.
OR an advanced degree with 5+ years of Program Manager experience in regulatory affairs supporting new drug, generics and combination products or another regulated industry in addition to experience with regulatory strategy and submissions.
Nice To Have
Bachelor's Degree in science, preferably in pharmacy, pharmacology, chemistry, or pharmaceutical technology.
Master’s degree is preferred; Ph. D. is highly preferred.
Thorough understanding of drug development process and FDA drug regulations.
Thorough understanding and familiarity with ICH guidelines, 21 CFR Part 11, 210, 211, and 820
Proven track record in successfully navigating the FDA new drug, generics, combination products, and post approval activities throughout the product lifecycle.
Ability to work independently to manage multiple projects in a fast-paced environment.
Ability to effectively collaborate and communicate the regulatory strategy, risks, mitigations and overall plans in a dynamic cross functional global team environment as well as clear and concisely to senior management.
Thorough understanding and familiarity with ISO 9001 and ISO 27001.
Demonstrate a strong understanding of pharmaceutical standards, guidelines, and FDA regulations and takes initiative to suggest and implement process improvements and follow through to completion.
Demonstrates an excellent understanding of global pharmaceutical requirements for investigational and marketing applications outside of the USA.
Experience with water purification systems resulting in sterile water.
Preparation of sterilization process validation section for regulatory filings.
Experience reviewing validation protocols for laboratory equipment, process equipment, and process validation.
Knowledge of medical devices (including knowledge of electronic/software-based devices) including but not limited to ISO 62304, IEC 62366.
Strong organization and time management skills.
Demonstrated ability to influence based on experience, facts and data.
Engineering the extraordinary
We tackle the most complex and challenging conditions people face with never-before-seen solutions.
People centered, data driven. We’re solving the world’s biggest health challenges with healthcare technology.
With 90,000 plus people in over 150 countries, we see extraordinary possibilities to further increase our positive impact in the world. We are committed to accelerating access to healthcare technology, advancing inclusion, diversity & equity and protecting our planet.