Director, Regulatory Affairs - Post Approval
- Rockville, MD, USA
- Department: Regulatory Affairs
Aurinia is a clinical stage biopharmaceutical company focused on developing and commercializing therapies in disease areas of high unmet medical need. We are currently developing voclosporin, an investigational drug, for the treatment of lupus nephritis (LN) and focal segmental glomerularsclerosis (FSGS). Additionally, we are advancing voclosporin ophthalmic solution (VOS), a topical formulation, for the treatment of dry eye syndrome (DES).
Reporting to the Head of Regulatory Affairs, the Director Regulatory Affairs – Post Approval will oversee and direct all global (including U.S.) regulatory support and submissions for commercial products. Primarily responsible for regulatory review of advertising and promotional materials, submission of the same and leading the cross-functional review committee within Aurinia.
Management of all post-approval regulatory activities for commercial products assigned to Regulatory Affairs:
• Leading the cross-functional review committee:
o Non-promotional materials used to support clinical trials and medical affairs information
o Advertising and promotional materials
• Regulatory review of advertising and promotional materials for commercial products, submission of the same
• First line regulatory affairs resource for marketing departments for commercial products
• Assist in the creation of and implementation of changes to product labeling including:
o Package inserts and structured product label (SPL).
o Medication Guides o Container labels
o Maintenance of regulatory archive of product labelling.
• Regulatory representative on project teams for commercial products; in particular for completion of post-marketing commitments, maintenance of establishment licenses, and product listings
• Manage the planning, preparation and technical review of post-marketing regulatory submissions and ensure submissions are completed to meet required/established timelines.
• Liaise with cross-functional marketing, commercial, CMC/Biologics and supply chain team members and external providers to ensure timely and effective regulatory submissions in support of commercial products
• Effect timely and appropriate regulatory management/strategic guidance of post-approval changes/lifecycle management for commercial products to internal groups such as marketing, quality assurance and manufacturing. Evaluate regulatory impact on BLA/NDA/MAA and make appropriate submissions (e.g., Annual Report, Supplements, Variations, Recalls).
• Provide regulatory support for due diligence activities associated with the assessment of business opportunities as necessary.
• Exercise good judgement in elevating and communicating actual or potential regulatory issues.
• Minimum BS/BA degree, advanced degree preferred
• Minimum of 12 years’ pharmaceutical drug development experience and at least 5 -7 years’ commercial regulatory experience (preferably recent), reviewing advertising and promotional materials (including online and social media/forums)
• Experience with direct interface with FDA Office of Prescription Drug Promotion
• Experience with creation and implementation of product labeling (SPL) highly desirable
• Solid working knowledge of US commercialization regulations and processes for pharmaceuticals and the ability to apply knowledge both strategically and operationally to commercial product regulatory issues
• Evidence of managing successful post approval submissions with FDA (EMA an asset) and demonstrated evidence of writing regulatory documents for commercial products
• Knowledge of eCTD elements and structure and regulatory technical writing skills
• Experience supporting and conducting due diligence activities
• Basic computer skills; MS Office, Excel and Adobe Acrobat
• Excellent skills in planning, organizing, decision-making, attention to detail and problem-solving
• Excellent communication (verbal, writing and presentation) skills and the ability to work collaboratively
• Ability to effectively delegate tasks and hold others accountable
• Excellent interpersonal and management skills
• Ability to independently as well as multi-task in a fast-paced atmosphere with multiple/changing priorities
• Willing to travel, both domestic and internationally up to 20% percent of the time
All your information will be kept confidential according to EEO guidelines.