-
Bristol-Myers Squibb Warren, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
-
Bristol Myers Squibb Company Warren, United States Full timeWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
-
Technician I Process Evaluation
3 weeks ago
Charles River Wayne, United StatesFor 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your backgr ...
-
Technician I Environmental Monitoring
1 week ago
Charles River Wayne, United StatesFor 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your backgr ...
-
Scientist II, Mass Spectrometry
1 week ago
Charles River Wayne, United StatesFor 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your backgr ...
-
Training Coordinator
2 days ago
Charles River Laboratories, Inc. Wayne, United StatesFor 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your backgr ...
-
Hematology/Oncology locums long term in Michigan
3 weeks ago
Hayman Daugherty Associates, Inc Detroit, United StatesJob Overview · Hematology/Oncology locums long term in Michigan · Hospital in Western Michigan is seeking a Board Certified Oncologist. Average 7 to 9 patients per day. Inpatient rounding in hospital from 7:00 to 5:00 and then on call to support the onsite APP's who are there 24/ ...
-
Research Assistant
3 weeks ago
Wayne State University Detroit, United StatesResearch Assistant - Department of Surgery · Wayne State University is searching for an experienced Research Assistant - Department of Surgery at its Detroit campus location. · Wayne State is a premier, public, urban research university located in the heart of Detroit, Michigan w ...
-
Research Assistant
3 weeks ago
Wayne State University Detroit, United StatesResearch Assistant - Department of Surgery · Wayne State University is searching for an experiencedResearch Assistant - Department of Surgeryat its Detroit campus location. · Wayne State is a premier, public, urban research university located in the heart of Detroit, Michigan whe ...
-
Regulatory Affairs Professional
1 week ago
Sartorius North America Detroit, United StatesSartorius, a leading international partner of life science research and the biopharmaceutical industry is expanding. · Sartorius has an exciting opportunity for a dynamic,self-motivated, Regulatory Affairs Professional to be based remotely in Michigan. The incumbent in this role ...
-
Medical Science Liaison
3 days ago
Bristol-Myers Squibb Detroit, MI, United StatesWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line t ...
-
Wayne State University Detroit, United StatesFaculty - Rank to be Determined - Dept of Oncology · Wayne State University is searching for an experiencedFaculty - Rank to be Determined - Dept of Oncologyat its Detroit campus location. · Wayne State is a premier, public, urban research university located in the heart of Detro ...
-
Wayne State University Detroit, United StatesFaculty - Rank to be Determined - Dept of Oncology · Wayne State University is searching for an experiencedFaculty - Rank to be Determined - Dept of Oncologyat its Detroit campus location. · Wayne State is a premier, public, urban research university located in the heart of Detro ...
-
Wayne State University Detroit, United StatesFaculty - Rank to be Determined - Dept of Oncology · Wayne State University is searching for an experienced Faculty - Rank to be Determined - Dept of Oncology at its Detroit campus location. · Wayne State is a premier, public, urban research university located in the heart of Det ...
-
Physical Therapy Assistant
1 week ago
Detroit Medical Center Detroit, MI, United StatesDetroit Medical Center is seeking a Physical Therapy Assistant for a job in Detroit, Michigan. · Job Description & Requirements · Specialty: Physical Therapy Assistant · Discipline: Therapy · Duration: Ongoing · 40 hours per week · Shift: 8 hours · Employment Type: Staff · DMC Un ...
-
Horizon Technologies Farmington, United StatesOur goal is to provide medical professionals with the best possible solutions so they can find the right answer for every challenge. Fresenius Kabi is a pioneer in the healthcare industry for the coming decade. We embrace diversity and value different personalities and attitudes. ...
-
Board Certified Behavior Analyst
2 weeks ago
Centria Autism Detroit, United StatesJob Description · Job DescriptionCentria Autism is the largest provider of Applied Behavior Analysis (ABA) for children with Autism Spectrum Disorder (ASD) across the state of Michigan, with services in 12 other states. Our mission is to help every child living with autism to dev ...
-
Senior Director, Medical Affairs
1 month ago
Fresenius Kabi USA LLC Detroit, United States Paid WorkJob Summary · The Senior Director, Medical Affairs will provide global medical leadership for the R&D function of the Fresenius Kabi MedTech business, which includes medical devices and solutions associated with transfusion, cell therapies, and infusion technology. Participate in ...
-
Technician I Cell Culture
1 month ago
Charles River Laboratories, Inc. Wayne, United StatesFor 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your backgr ...
-
Technician I Virology
2 days ago
Charles River Laboratories Wayne, United States**Req ID #**:223369**Location**:Wayne, PA, US, For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being ...
Senior Manager, Regulatory Affairs Cell Therapies - Detroit, United States - Fresenius Kabi
Description
Job Summary
The Senior Manager, Regulatory Affairs position will support the Regulatory Affairs (RA) Director to help define the regulatory strategy for our innovative next-generation technology for cellular therapy. This position will play a substantial role researching regulations, defining and implementing the regulatory strategy and engaging with health authorities to effectively inform our development programs. The successful candidate should possess a scientific background and will have an understanding of the unique aspects of cell therapy. The ability to deal with ambiguity and think outside the box are critical for this position.
*While this position can be worked remotely, qualified candidates must reside in the U.S. and be permanently authorized to work in the U.S.
Responsibilities
Work under the director of the RA Director to craft the health authority engagement strategy and interaction plan, drive the formulation of the meeting package, lead the team through meeting rehearsals (if needed) and may moderate the meeting itself. Prepare, review, compile, and archive regulatory submissions and correspondence. Submission types can vary, may include: Investigational New Drug (IND) applications, Biological License Applications (BLA), Regenerative Medicine for Advanced Therapy (RMAT) Applications, Investigational Device Exemption (IDE), 510(k), and other submissions as necessary. Work with RA partners at stakeholder organizations to further refine the overall RA strategy. Ensure project teams, deliverables and business objectives are aligned with RA strategy. Provide strategic and technical input for regulatory decisions. Respond to regulatory agency questions within defined timeline. Monitor emerging regulation changes which have the potential to impact these products and identify impact or solution.
Job Requirements Bachelor's Degree required with 8+ years of experience in a regulatory function. 2+ years of experience in Cell Therapy. Demonstrated experience in regulatory filings and support for CGT/ATMP products. Ability to work strategically within a business critical and high-profile development program. Experience in preparing regulatory submissions, such as INDs and BLA/NDA. Proven effective collaboration with regulatory agencies. A solid knowledge of regulatory affairs, including proven track record of regulatory drug development and experience with major health authority interactions. Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component. Established working knowledge of regulatory guidelines and regulations including Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines (e.g., ICH, FDA and EMA guideline).
Salary range: $140,000-180,000 base + 14% annual bonus
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company match, andwellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.