Current jobs related to Manager, Regulatory Affairs - North Andover - Fresenius Kabi USA, LLC
-
Regulatory Affairs Manager
7 days ago
North Chicago, Illinois, United States AbbVie Full timeJob SummaryThe Senior Manager, Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) plays a critical role in ensuring the successful delivery of products to patients. This position requires a strategic thinker who can develop and implement effective CMC regulatory strategies, build strong relationships with internal and external partners, and...
-
North Chicago, Illinois, United States US Tech Solutions Full time**Job Summary**US Tech Solutions is seeking a highly skilled Associate Regulatory Affairs Submission Management to join our team. As a key member of our regulatory affairs team, you will be responsible for managing low to medium impact submission projects involving multiple cross-functional regulatory submission teams.Key Responsibilities:Manage submission...
-
North Chicago, Illinois, United States US Tech Solutions Full timeUS Tech Solutions is seeking a skilled Regulatory Affairs Submission Management professional to join our team. The ideal candidate will have experience managing low to medium impact submission projects involving multiple cross-functional regulatory submission teams. Key responsibilities include: * Collaborating with regulatory submission teams to ensure...
-
Regulatory Affairs Specialist
3 weeks ago
North Chicago, Illinois, United States Collabera Full timeHome Search Jobs Job Description Regulatory Affairs Associate Contract: North Chicago, Illinois, US Salary: $30.00 Per Hour Job Code: End Date: Job Description: Key Responsibilities:Assist in the preparation of regulatory submissions for various product categories including Food, FSMP, Enteral Nutrition, and Pharmaceuticals. Demonstrate proficiency in...
-
Senior Manager, Regulatory Affairs CMC
1 week ago
North Chicago, Illinois, United States AbbVie Full timeJob SummaryThe Senior Manager, Regulatory Affairs CMC will work closely with internal and external partners to deliver products to patients. This role will be responsible for developing and managing content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations.Key...
-
Regulatory Affairs Specialist
3 weeks ago
North Chicago, Illinois, United States Collabera Full timeHome Search Jobs Job Description Regulatory Affairs Associate Contract Type: Temporary Location: North Chicago, Illinois, US Compensation: $30.00 Per Hour Job Overview: As a Regulatory Affairs Associate, you will play a crucial role in supporting regulatory submissions for various product categories including Food, FSMP, Enteral Nutrition, and...
-
Regulatory Affairs Director
1 week ago
North Chicago, Illinois, United States AbbVie Full timeJob SummaryAbbVie is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring the successful execution of post-approval change objectives for marketed products.Key ResponsibilitiesProject Management: Independently manage, compile, and author CMC sections...
-
Regulatory Affairs Specialist
3 weeks ago
North Chicago, Illinois, United States Collabera Full timeHome Search Jobs Job Description Regulatory Affairs Associate Contract Type: Contract Location: North Chicago, Illinois, US Compensation: $30.00 Per Hour Job Overview: Responsibilities:Assist in the preparation and submission of regulatory documents for various product categories including Food, FSMP, Enteral Nutrition, and Pharmaceuticals. Demonstrate...
-
North Chicago, Illinois, United States AbbVie Full timeJob SummaryThe Senior Manager, Regulatory Affairs CMC will lead the development and implementation of regulatory strategies to ensure compliance with global regulations and guidelines. This role will work closely with internal and external partners to deliver high-quality products to patients.Key ResponsibilitiesDevelop and implement CMC regulatory...
-
Regulatory Affairs Associate
3 weeks ago
North Chicago, United States SPECTRAFORCE Full timeJob Title: Associate Regulatory Affairs Submission ManagementLocation: Lake County AP50, or Florham Park, NJDuration:12 months 7. What are the top 3-5 skills, experience or education required for this position:1. eCTD submission publishing (advertising and promotional 2253 submissions if possible)2. US regulatory FDA guidelines/CFR3. submission/regulatory...
-
Regulatory Affairs Specialist
7 days ago
Mooresville, North Carolina, United States Gentiva Full timeAbout GentivaGentiva is a leading provider of healthcare services, specializing in hospice, palliative, home health, and personal care. Our mission is to deliver high-quality, patient-centered care that makes a meaningful difference in people's lives.Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be...
-
North Chicago, United States US Tech Solutions Full timeDuration: 1 year Employment Type: W-2 Overview: The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines,...
-
Regulatory Affairs Specialist Senior
3 weeks ago
Mooresville, North Carolina, United States Gentiva Full timeRegulatory Affairs Specialist SeniorGentiva, a leading provider of healthcare services, is seeking a highly skilled Regulatory Affairs Specialist Senior to join our team.About the RoleThis is an exciting opportunity to contribute to the development and implementation of regulatory strategies that support our company's growth and compliance with government...
-
North Chicago, United States US Tech Solutions Full timeDuration: 1 yearEmployment Type:W-2 Overview:The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams.With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates...
-
North Chicago, IL, United States US Tech Solutions Full timeDuration: 1 yearEmployment Type: W-2 Overview:The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams.
-
Senior Manager, Regulatory Affairs Operations
2 weeks ago
North Chicago, Illinois, United States AbbVie Full timeJob SummaryThe Senior Manager, Regulatory Strategic Planning, is a key member of the AbbVie team responsible for delivering project management capabilities for cross-functional teams of medium- to high-complexity within and across the Regulatory Affairs organization.Key ResponsibilitiesProject Management Leadership: Provides project management leadership in...
-
Regulatory Affairs Coordinator
3 weeks ago
North Chicago, Illinois, United States SPECTRAFORCE Full timeJob Title: Regulatory Affairs AssociateLocation: RemoteDuration: 03+ monthsThis position offers the flexibility of being fully remote or hybrid.Role Overview:In this role, you will be responsible for the organization and preparation of documentation for regulatory submissions under general supervision.Assess and analyze technical and scientific data and...
-
Regulatory Affairs Associate I
4 weeks ago
North Chicago, United States Collabera Full time $28 - $32Job DescriptionJob Description· What are the top 3-5 skills, experience or education required for this position:· eCTD submission publishing (advertising and promotional 2253 submissions if possible)· US regulatory FDA guidelines/CFR submission/regulatory project management Veeva Promomats...
-
Manager, Regulatory CMC Strategy
2 weeks ago
Andover, United States Pfizer Full timeWhy Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...
-
Regulatory Affairs Associate
3 months ago
North Chicago, United States Collabera Full timeJob DescriptionJob Description· Support Regulatory submissions for Food, FSMP, Enteral Nutrition, IF & FUF, Drug for EURI/ MENAP/ global. Possess well developed skills in supporting development of product registration dossiers, submission, progress reports, deficiencies, amendments, etc …· Support teams to develop...
Manager, Regulatory Affairs
4 months ago
Job Summary The Manager, Regulatory Affairs is responsible for defining and implementing regulatory strategies and submissions in support of new and existing market authorizations. Participate on cross-functional project teams and act as global regulatory advisor. This position will be supporting Infusion Systems within Regulatory Affairs.
** This is a hybrid position and requires working on-site 3 days per week in North Andover, MA. Responsibilities
Represent Regulatory on assigned product/project teams; establish and implement regulatory strategies that align with project objectives
Develop and execute regulatory plans for complex projects including new product development, new registrations, product modifications, maintenance of existing licenses, and ongoing compliance activities
Strategize and prepare local and global regulatory submissions for assigned projects
Monitor applicable regulatory requirements for products within area of responsibility and inform product/project teams of upcoming changes in applicable regulations and guidance documents
Perform gap analyses and propose solutions to ensure compliance with local and global regulations as well as internal and external standards
Establish and maintain appropriate communication within Regulatory and across other functions primarily at project level
Develop and document sound regulatory decisions and justifications
Interact with regulatory agencies for assigned projects/submissions as directed by supervisor; respond to (or help with) regulatory agency questions within defined timelines
Review and approve product labeling and advertising/promotional materials for compliance with applicable regulatory requirements
Review technical documentation for suitability to support regulatory applications
Act as regulatory project manager on assigned projects. Collaborate with subject matter experts and drive project team to achieve established regulatory submission timelines
Mentor and train other regulatory staff
Requirements
Bachelor's degree with minimum of 6 years' experience in a function such as regulatory, quality, or clinical in the life sciences industry, OR high school diploma with minimum of 8 years' experience in medical device or pharmaceutical regulatory affairs
Experience in authoring infusion system applications to FDA is highly preferred (e.g., pre-subs, 510(k)s, IDEs)
Sound regulatory and scientific knowledge
Experience and proven effective collaboration in a multicultural environment
Strong oral and written communication and presentation skills
Demonstrated interpersonal skills including strong negotiation skills
Ability to manage complex projects and timelines in a matrix team environment
Ability to independently identify compliance risks and escalate when necessary
Ability to lead and coach others
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.
#J-18808-Ljbffr
