Location: Montpelier,VT, USA
**_What Regulatory Affairs and Clinical Submissions contributes to Cardinal Health_**
The _Manager, Regulatory Affairs (Clinical Submissions)_ is responsible for ensuring compliance with regulatory requirements for clinical trials and products. This role involves providing strategic regulatory support across the lifecycle of clinical research, development of clinical development plans, development of regulatory paths for products, preparing and managing regulatory submissions, and acting as a liaison between the organization and regulatory agencies.
**Location** - Fully remote (candidates can reside nationwide)
**Responsibilities**
+ **Regulatory Submissions & Documentation**
+ Preparation, review, and manage the submission of regulatory, clinical documents, including INDs, NDAs, BLAs, CTAs, and other filings to regulatory authorities (FDA, EMA, etc.).
+ Manage and ensure timely submission of regulatory, and clinical documents to meet project timelines and milestones.
+ Maintain regulatory filings and documentation in accordance with regulatory agency requirements and internal standards.
+ **Regulatory Compliance**
+ Ensure ongoing compliance with applicable regulations (e.g., FDA, EMA, ICH, GxP) throughout the life cycle of clinical development.
+ Monitor and interpret changes in regulatory policies, guidance, and legislation and communicate relevant updates to stakeholders.
+ Support audits and inspections from regulatory bodies.
+ **Regulatory Strategy Development**
+ Lead the development and implementation of regulatory strategies to support clinical trial designs, product development, and commercialization.
+ Provide regulatory input and review or preparation of clinical trial protocols, labeling, meeting documents, and product dossiers.
+ Ensure alignment with global regulatory requirements for clinical trials and marketing applications.
+ **Cross-functional Collaboration**
+ Work closely with clinical operations, project management, medical affairs, legal, medical writing, nonclinical, and quality teams to ensure regulatory compliance in clinical trial execution and product development.
+ Provide regulatory guidance and advice to cross-functional teams to support clinical trial design, implementation, and data interpretation.
+ **Regulatory Agency Interaction**
+ Serve as the primary point of contact or US Agent for regulatory authorities for assigned products or projects.
+ Represent and lead the organization in meetings with regulatory authorities to resolve issues and negotiate submission requirements or timelines.
+ **Leadership & Team Development**
+ Lead, mentor, and develop junior regulatory affairs staff, providing training and guidance on regulatory processes.
+ Contribute to the development and improvement of internal regulatory processes and standard operating procedures (SOPs).
**Qualifications**
+ Bachelor's degree in life sciences, pharmacy, or related field (preferred) with an advanced degree (MS, MD, PhD, or JD) also a plus.
+ 8+ years of regulatory affairs experience with demonstrated leadership responsibilities, preferred.
+ Strong knowledge of global regulatory requirements (FDA, EMA, ICH, etc.) and clinical trial regulations.
+ Experience with preparation and review of regulatory submissions (e.g., INDs, NDAs, CTAs) and interactions with regulatory authorities, preferred.
+ Proficiency in regulatory affairs software, writing software, and electronic eCTD submission systems, highly preferred.
+ Proficient in the preparation/authoring and review of regulatory and clinical documents (etc. Module 1 admin and labeling documents, Module 2 clinical documents, and Module 5 clinical documents), highly preferred.
+ Ability to prepare meeting documents, lead FDA meetings and actively participate, including experience preparing designation requests for FDA, highly preferred.
+ Prior client facing experience, preferred.
+ Strong problem-solving and decision-making skills with a high attention to detail.
+ Experience with drugs and biologics, with medical devices or combination products, highly preferred.
+ RAC certification, preferred.
+ Experience in managing global regulatory submissions and verbal and written interactions with regulatory agencies, preferred.
+ Leadership experience, to lead and manage projects and with the ability to mentor and guide junior staff, preferred.
+ Ability to work independently, manage multiple priorities, and meet deadlines in a fast-paced environment.
+ Excellent written and verbal communication skills, including the ability to effectively communicate complex regulatory concepts.
**_What is expected of you and others at this level_**
+ Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
+ Participates in the development of policies and procedures to achieve specific goals
+ Recommends new practices, processes, metrics, or models
+ Works on or may lead complex projects of large scope
+ Projects may have significant and long-term impact
+ Provides solutions which may set precedent
+ Independently determines method for completion of new projects
+ Receives guidance on overall project objectives
+ Acts as a mentor to less experienced colleagues
#LI-LP
#LI-remote
**Anticipated Pay Range** $121,600.00 - 173,650.00 USD
**Bonus Eligible** - Yes
**Benefits** : Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
+ Medical, dental and vision coverage
+ Paid time off plan
+ Health savings account (HSA)
+ 401k savings plan
+ Access to wages before pay day with myFlexPay
+ Flexible spending accounts (FSAs)
+ Short- and long-term disability coverage
+ Work-Life resources
+ Paid parental leave
+ Healthy lifestyle programs
**Application window anticipated to close** : 12/15/2024 * if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
_Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._
_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._
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