Sr Manager, Commercial Regulatory

Duties And Responsibilities

• 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.
• Supports 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.