Regulatory Manager Strategy and Labeling (Remote)
Location: Fort Collins, Colorado
Purpose and Scope
Responsible for providing regulatory strategy and regulatory guidance for nonclinical, clinical and labeling regulatory aspects of Tolmar’s proprietary products and development programs. 0versight of Target Product Profile (TPP), Company Core Data Sheet (CCDS), claims definition and submission building and management of the nonclinical and clinical modules. Knowledge of FDA regulations and guidance’s governing drugs in all phases of development, in addition to general awareness of international requirements.
Essential Duties & Responsibilities
- Aid in the development of regulatory strategic plans in conjunction with project teams and assist in the design of nonclinical and clinical study programs required for regulatory approval.
- Regulatory project lead in coordinating the preparation, review and submission of nonclinical and clinical modules of regulatory dossiers (IND/CTA/NDA/MAA submissions).
- Develop and implement timelines and performance requirements in conjunction with CMC Lead for regulatory projects.
- Execute strategy for submissions of product registration documents to health authorities worldwide.
- Interact with other functions in the preparation, review, and completion of documents for regulatory submissions.
- Provide interpretation of regulatory authorities' feedback, policies and guidelines to staff.
- Work with project teams to resolve complex project issues.
- Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to help ensure approvals.
- Work in close collaboration cross functionally and with Regulatory Affairs management to prepare Agency meeting requests and background packages such as pre-IND and NDA meetings.
- Develop and implement timelines and performance requirements for regulatory projects.
- Act as liaison between Regulatory Agencies, Marketing Partners and the company as required.
- Assure compliance with project team timelines and milestones.
- Provide organizational support and manage staff as company grows its product development pipeline.
- Oversee and advise employees on draft investigational and commercial labeling artwork, and review and approval of promotional materials for commercial product.
- Perform other duties as assigned.
Knowledge, Skills & Abilities
- Working knowledge of the CFRs and the ability to understand and interpret domestic and international governmental regulations/guidelines and apply them so that regulatory requirements are met.
- Strong verbal and written communication, detail-oriented with a commitment to accuracy, as the position will potentially interface with key opinion leaders and employees.
- Self-motivated with initiative and the ability to take ownership of, and follow through with specific tasks.
- Ability to multi-task and shift priorities quickly while working under tight deadlines.
- Skilled in developing collaborative internal and external relationships.
- Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint). Familiarity and ability to work directly with various eCTD publishing systems a plus.
- The Regulatory Manager, Strategy and Labeling is expected to operate within the framework of Tolmar’s Core Values:
- Consistently operate with the highest standards of ethics and compliance.
- Take ownership of your actions, success and setbacks.
- Respect each other and understand that honest collaboration is at the heart of our company success.
- Go the extra mile to make things happen.
- Be committed to all we do and the patients we serve.
- Embrace change with enthusiasm.
- Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.
Education & Experience
- Bachelor’s Degree in scientific field required. Master’s degree preferred.
- Seven or more years’ experience in Regulatory Affairs in the pharmaceutical/biologic industry with the responsibility for preparing and submitting electronic regulatory applications.
- RAC certification preferred.