Current jobs related to (Contractor) Senior Manager Regulatory Affairs - Noblesville - Curium

  • (Contractor) Senior Manager Regulatory Affairs

    7 months ago

    Noblesville, United States Curium Live Forward Full time

    Summary of Position The Senior Manager of Regulatory Affairs is responsible for Nuclear Medicine Regulatory Affairs dossiers and associated regulatory affairs activities in the US. The responsibilities include, yet are not limited to, defining and or authoring compliant content for new and existing dossiers, implementing and managing tracking systems,...

  • Senior Manager Regulatory Affairs Lead

    1 month ago

    Noblesville, Indiana, United States Curium Live Forward Full time

    Job Title: Senior Manager Regulatory AffairsCurium Live Forward is seeking a highly skilled Senior Manager Regulatory Affairs to join our team. As a key member of our Regulatory Affairs department, you will be responsible for leading the development and implementation of regulatory strategies for our Nuclear Medicine products.Key Responsibilities:Manage...

  • Senior Manager Regulatory Affairs Lead

    2 weeks ago

    Noblesville, Indiana, United States Curium Live Forward Full time

    Job SummaryThe Senior Manager Regulatory Affairs will play a pivotal role in driving the success of key regulatory projects at Curium Live Forward. This position requires a highly skilled and experienced individual capable of navigating the complex regulatory landscape related to CMC.Key ResponsibilitiesManage submissions and projects as assigned by...

  • Senior Construction Manager

    2 days ago

    Noblesville, United States Midas Building Group Full time

    At Midas Building Group, we're seeking a highly skilled Senior Construction Manager to lead our commercial construction projects to success.Key Responsibilities:Implement and enforce field safety protocols and reportingOversee quality assurance and identify potential issuesProduce RFIs, submittals, and change order requestsReview drawings and...

  • Senior Manager Quality Assurance

    4 weeks ago

    Noblesville, United States Curium Pharma Full time

    Senior Manager Quality AssuranceDate: Sep 20, 2024Location: Noblesville, IN, United States About Curium Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a...

  • Senior Operations Manager

    1 week ago

    Noblesville, Indiana, United States Prime Car Wash Full time

    Job Title: Senior Operations ManagerPrime Car Wash is seeking a highly skilled Senior Operations Manager to lead our team of professionals in delivering exceptional customer experiences and driving business growth.Key Responsibilities:Manage day-to-day operations of the car wash facility, ensuring seamless execution of processes and procedures.Recruit,...

  • Director of Community Marketing

    1 month ago

    Noblesville, Indiana, United States American Senior Communities Full time

    About the Role:The Director of Community Marketing will be responsible for developing and implementing a marketing plan to support multiple ASC communities. This includes identifying and developing growth of new business relationships, referral sources, and global professional referrals.Key Responsibilities:Provides appropriate and pertinent information...

  • Senior Environmental Compliance Specialist

    3 weeks ago

    Noblesville, United States Utilities Service Co Inc Full time

    Job Title: Senior Environmental Oversight TechnicianWe are seeking a highly skilled Senior Environmental Oversight Technician to join our team at Utilities Service Co Inc. This is a field-based position that requires a strong understanding of environmental compliance and construction oversight.Key Responsibilities:Provide environmental compliance and...

  • Director of Community Marketing

    4 months ago

    Noblesville, United States American Senior Communities Full time

    Director of Community Marketing What will you be doing and how will you make a difference at American Senior Communities? Provides appropriate and pertinent information regarding American Senior Communities services to potential customers Identifies and develops growth of new business relationships, referral sources and global professional...

  • Director of Community Engagement

    2 months ago

    Noblesville, Indiana, United States American Senior Communities Full time

    Job Summary:The Director of Community Engagement will be responsible for developing and implementing a comprehensive marketing strategy to promote American Senior Communities' services to potential customers. This role will identify and develop new business relationships, referral sources, and professional referrals to drive growth and revenue.Key...

  • Senior Financial Leader

    3 weeks ago

    Noblesville, United States Creative Financial Staffing Full time

    {"h1": "Senior Accountant Role at Creative Financial Staffing", "p": "At Creative Financial Staffing, we are seeking a highly skilled Senior Accountant to join our team. As a Senior Accountant, you will play a critical role in driving financial accuracy, compliance, and strategic insights. This is a unique opportunity to lead financial reporting, analysis,...

  • Senior Environmental Compliance Specialist

    4 weeks ago

    Noblesville, Indiana, United States Environmental Consultants (ECI) Full time

    Job Title: Senior Environmental Oversight TechnicianWe are seeking a highly skilled and experienced Senior Environmental Oversight Technician to join our team at Environmental Consultants (ECI). As a key member of our team, you will be responsible for providing environmental compliance and construction oversight on transmission site development and linear...

  • Senior Operations Manager

    6 days ago

    Noblesville, Indiana, United States AEG Full time

    Job SummaryThe Senior Operations Manager will oversee the day-to-day operations of the Noblesville Event Center, ensuring a consistently superior and innovative experience for guests. This role is responsible for managing the venue's operations, including live entertainment booking, sales and sponsorship, event production, event management, and related...

  • Senior Quality Assurance Specialist

    1 month ago

    Noblesville, United States Curium Pharma Full time

    About the RoleWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Curium Pharma. As a key member of our quality team, you will be responsible for ensuring the accuracy, integrity, and regulatory compliance of documents in a regulated environment.Key ResponsibilitiesReview and edit documents for accuracy, completeness, and...

  • Senior Quality Assurance Specialist

    4 weeks ago

    Noblesville, Indiana, United States Curium Pharma Full time

    About Curium PharmaCurium Pharma is a leading pharmaceutical company with a rich history of innovation and excellence. Our mission is to deliver high-quality products that improve the lives of patients worldwide.Job SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team. The successful candidate will be responsible for...

  • Senior Manager Quality Assurance

    3 weeks ago

    Noblesville, Indiana, United States Curium Pharma Full time

    Job Title: Senior Manager Quality AssuranceCurium Pharma is seeking a highly experienced Senior Manager Quality Assurance to join our team. As a key member of our quality operations team, you will be responsible for ensuring the highest standards of quality and compliance in our radiopharmaceutical manufacturing facility.Key Responsibilities:Develop and...

  • Senior Environmental Oversight Technician

    4 weeks ago

    Noblesville, United States Utilities Service Co Inc Full time

    We are currently seeking a Senior Environmental Oversight Technician to collaborate with large scale electric transmission construction projects. This is a field position, and the candidate must have experience with environmental compliance in relation to Site Development and Transmission Linear construction projects. We are looking for an energetic...

  • Director of Community Marketing

    2 weeks ago

    Noblesville, Indiana, United States American Senior Communities Full time

    Job Title: Director of Community MarketingAbout the Role:We are seeking a highly skilled and experienced Director of Community Marketing to join our team at American Senior Communities. As a key member of our marketing team, you will be responsible for developing and implementing marketing strategies to promote our senior living communities and services.Key...

  • Nursing Director

    1 week ago

    Noblesville, Indiana, United States American Senior Communities Full time

    About the RoleWe are seeking a highly skilled and experienced Nursing Director to join our team at American Senior Communities. As a key member of our leadership team, you will be responsible for developing and implementing nursing policies and procedures that reflect current clinical practice and professional standards.Key ResponsibilitiesDevelop and...

  • Microbiologist Manager

    4 weeks ago

    Noblesville, Indiana, United States Curium Pharma Full time

    Job Title: Manager Quality Control MicrobiologyCurium Pharma is seeking a highly skilled and experienced Manager Quality Control Microbiology to join our team. As a key member of our quality control department, you will be responsible for ensuring the highest standards of quality and compliance in our microbiology laboratory.Key Responsibilities:Manage and...

(Contractor) Senior Manager Regulatory Affairs

3 months ago

Noblesville, United States Curium Full time
About Curium

Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name 'Curium' honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline 'Life Forward' represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

Summary of Position

The Senior Manager of Regulatory Affairs is responsible for Nuclear Medicine Regulatory Affairs dossiers and associated regulatory affairs activities in the US. The responsibilities include, yet are not limited to, defining and or authoring compliant content for new and existing dossiers, implementing and managing tracking systems, and preparation of electronic submissions. This position requires a highly skilled and experienced individual capable of navigating the complex regulatory landscape related to CMC. The main focus of this position will be on new submissions associated with new chemical entity (NCE) with a secondary focus on existing marketed products or those obtained through acquisition.

This position will facilitate the success of key regulatory projects that may require concept building, Target Product Profile (TPP), claims definition, regulatory strategy (including non-clinical and clinical), Non-clinical and clinical protocol review, defining dossier Table of contents, submission building, health authority management, obtaining approvals, managing post-approval commitments, and product launch. The regional focus for project deliverables is North America, that is, Food and Drug Administration and Health Canada, although the position will rely on the Canadian RA staff for country-specific regulations.

The Senior Manager Regulatory Affairs will directly participate in project teams managing key projects, regulatory deliverables, prioritization, strategy, providing guidance, and tracking regulatory process. The Senior Manager is expected to be able to identify risk and make risk-based decisions to facilitate solutions for process and submission. The candidate will direct and mentor less experienced staff on Risk-Based Decision making.

Essential Functions

  • Manage submissions and projects as assigned by Regulatory leadership assuring compliance, planning, and execution
  • Represent regulatory on cross-functional teams
  • Process, interpret and provide recommendations for complex strategies
  • Provide regulatory and technical expertise to cross-functional teams
  • Critically review documentation for regulatory submissions and provide input for necessary revisions
  • Develop and implement regulatory strategies for CMC aspects of drug development and registration
  • Lead the preparation and submission of CMC sections of regulatory documents (e.g., INDs, NDAs, BLAs, MAAs) in compliance with global regulations and guidelines
  • Contribute to defining Target Product Profile and build compliant drug "approvable" dossiers and registration
  • Serve as Liaison for third party service providers
  • Maintain associated database for tracking individual and department project deliverables for regulatory submissions and milestones
  • Develop and implement policies, procedures, practices, and strategies for Regulatory Affairs, based on current Health Authority guidelines and regulations
  • Manage multiple, sometimes conflicting priorities, define issues and obstacles, define risk analysis and execute solutions
  • Execute objectives in alignment with Regulatory leadership, Marketing, and Global Business Units
  • Communicate regulatory governmental policy changes to management in a timely manner and provide plans for meeting and complying with new requirements. Understand and recommend strategies based on current local registration requirements and applicable industry standards
  • Supports the professional development of regulatory staff through mentorship and guidance
  • Present to upper management at required intervals and effectively communicate successes and challenges
  • Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)
Requirements
  • Bachelor of Science in Chemistry, pharmacy, biology or other life science, plus direct experience managing regulatory activities.
  • Twelve or more years of relevant Regulatory Affairs pharmaceutical industry experience.
  • Two years of supervisory experience of direct reports required, matrix management experience preferred.
  • In-depth knowledge of global CMC regulatory requirements, guidelines, and industry practices.
  • Experience in leading new project submission efforts including strategy, compilation, submission, and approval by a health authority.
  • Experience writing Target Product Profiles, non-clinical studies, reviewing Clinical protocols and summary reports.
  • Preparing for and executing Health Authority meetings.
Working Conditions:
  • Standard office environment.
  • Willingness to work in a team-based environment.
  • May be required to sit or stand for long periods of time while performing duties.
  • Close attention to detail required.
  • Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.


Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Equal Opportunity Employer

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Job Segment: Regulatory Affairs, Compliance, Medical Technologist, Medical Research, Clinical Research, Legal, Healthcare