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The Sr. Manager Commercial Regulatory supports regulatory department with cross-functional projects, submission requirements, and specific regulatory and development initiatives as required. I

DUTIES AND RESPONSIBILITIES:

The following reflects management’s definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons:

Serves as a Commercial RA representative on project teams, as assigned.

Capable of independent leadership for projects assigned.

Acts as a final, independent reviewer and approval signatory for Commercial regulatory packages (e.g., labeling supplements).

Leads preparation and cross-functional review of content for cover letters, relevant background information, and any other material for regulatory bodies and assures integrity of all related submissions.

Leads preparation of content for responses to FDA requests for information for commercial topics (e.g., labeling, promotional materials).

Works with other regulatory departments to prepare new product marketing submissions for the FDA as required (NDA, ANDA, BLA, & related supplements).

Provides information for content of periodic reports (e.g., marketing application annual reports, IND annual reports, and periodic safety reports).

Commercial RA representative in labeling discussions; draft/edit labeling; prepare labeling submissions; and archive labeling for future revisions and annual reports.

Independently develop project timelines and budgets, as required.

Research, compile, and interpret information as required to support company regulatory initiatives with a focus on promotional material, tradename development, and labeling development projects.

Leads the review for the Regulatory team during Medical/Legal/Regulatory promotional review sessions and is responsible for the electronic submission of promotional materials for all products to the Office of Prescription Drug Promotion (OPDP).

Represents regulatory affairs at Sales Team Meetings to reinforce FDA rules as they apply to promotional material.

Responsible for ensuring compliance of promotional material with FDA regulations through FDA Form 2253 and preclearance submissions of standard and Subpart H promotional materials to OPDP.

Coordinates and responds to advisory letters received by OPDP regarding USWM products. Tracks, summarizes, and electronically files all advisory letters received by other companies from OPDP.

Routinely checks status of competitor approvals and marketing materials.

Tracks progress and deadlines of multiple projects under the direction of a regulatory lead.

Supports information requests from regulatory agencies.

Supports regulatory senior management in the development of contracts and verification of invoicing and deliverables against agreed terms.

Prepares and reviews content for cover letters, relevant background, and any questions for regulatory bodies to accompany the company’s regulatory applications (e.g., INDs, NDAs, as applicable).

Helps prepare and reviews content for responses to FDA requests for information.

Develops and maintains working knowledge of regulations/guidances/regulatory landscape for focus area, to include international regulations, as needed.

Research and compile data for regulatory department as requested to support other project requirements.

Maintains team skills and readiness during mergers, acquisitions, and divestitures.

Contributes to the development and implementation of regulatory processes and procedures (e.g., SOPs and Work Instructions).

Trains regulatory Commercial Associate and Specialists on labeling and promotional FDA guidelines.

Trains on and maintains responsibility for other regulatory department duties as assigned (e.g., assistance with preparation of state pharmacy board license applications, assistance with upkeep of regulatory budget tracking, and/or department invoice coding).

Supports efforts on new technology selection, implementation, and improvements.

Assists submissions personnel in maintenance of Regulatory Affairs documentation, as required.

QUALIFICATIONS

Minimum Bachelor’s Degree in Life or Engineering Science, advanced science, or medical related degrees desirable

Minimum 3 years’ experience working in a Regulatory role within a pharmaceutical environment.

Proficient writing and strong organizational skills required.

Must be able to complete and prioritize multiple projects simultaneously.

Demonstrated communication and human relation skills.

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL DEMANDS

Frequently required to stand
Frequently required to walk.
Frequently required to sit.
Frequently required to talk or hear.
Occasionally required to lift light weights (less than 25 pounds)
Specific vision abilities required for this job include: close vision, color vision and ability to adjust or focus

WORK ENVIRONMENT

The noise level in the work environment usually is quiet.
Must be able to travel with overnight stays, as necessary

Equal opportunity employer, and does not discriminate on the basis of race, color, religion, sex, pregnancy, national origin, disability, age, genetic information, veteran status, sexual orientation, gender identity or any other characteristic protected by federal, state or local law.

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Sr Manager, Commercial Regulatory in Louisville, Kentucky at USWM, LLC

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