Senior Manager, Regulatory Affairs

Company: Aurinia Pharmaceuticals
Location: Rockville
Posted on: September 13, 2020

Job Description:

We are currently developing voclosporin, an investigational therapy, for the treatment of lupus nephritis (LN) and other proteinuric diseases. We are also advancing voclosporin ophthalmic solution (VOS), a topical formulation, for the treatment of dry eye syndrome (DES). And we are actively hunting for other innovative drugs which have the potential to change the lives of people with rare autoimmune and inflammatory diseases.

Job Description This role is responsible for regulatory review and approval of commercial materials for Aurinia’s products/indications. This role provides regulatory advice on promotional materials and activities for Aurinia’s products in accordance with business strategy, goals and objectives, FDA regulations/ guidelines, and Aurinia policy. The Senior Manager will partner with the commercial teams and others to implement compliant product labeling, materials, and communications. The scope for this role includes Promotional, Clinical, Sales Training, and Corporate materials.

Reporting to the Director of Regulatory Affairs, this role will execute important duties, primarily:

Ensuring regulatory compliance of marketed products

Assuring timely submissions to FDA OPDP (Office of Prescription Drug Promotion)

Establishing/maintaining strong relationships with cross-functional stakeholders in the MLR (Medical, Legal, Regulatory) process

RESPONSIBILITIES:

This role is concerned with management of post-approval regulatory activities for commercial products assigned to Regulatory Affairs. Responsibilities include:

Regulatory review of advertising and promotional materials, commercial training materials, product labeling changes, and other select non-promotional materials for commercial products to ensure: Compliance with applicable FDA regulations, guidance documents, and OPDP letters

Materials are consistent with approved product labeling

Materials are not false or misleading, have fair balance (product risks vs benefits), and do not omit material facts in light of representations made

Inclusion of prescribing information or brief summary as required

Attend MLR Committee and related meetings regularly to discuss comments/issues with materials

Clearly communicate regulatory recommendations to cross-functional teams

Manage the planning, preparation, and technical review of post-marketing regulatory submissions to OPDP and ensure submissions are completed to meet required/established timelines

Serve as primary liaison between Aurinia and FDA OPDP

Assist in the creation of and implementation of changes to product labeling including: Package Inserts and structured product label (SPL)

Medication Guides/Patient Package Inserts (PPI)

Container labels

Maintenance of regulatory archive of product labeling

Keep up with regulatory/industry environment, including guidances, enforcement, and trends within pharma

Research regulatory issues impacting promotion

Participate in cross-functional reviews and committees representing Regulatory ad/promo

Exercise good judgment in elevating and communicating actual or potential regulatory issues

Qualifications Minimum BS/BA degree, advanced degree preferred

Minimum 7 years pharmaceutical drug development experience and at least 3-5 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

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 and demonstrated evidence of writing regulatory documents for commercial products

Knowledge of eCTD elements and structure and regulatory technical writing skills

Basic computer skills; MS Office, Excel and Adobe Acrobat; EDMS such as Veeva Vault a plus

Excellent skills in planning, organizing, decision-making, attention to detail, and problem-solving

Excellent verbal and written communication skills and the ability to work collaboratively

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

Additional Information All your information will be kept confidential according to EEO guidelines.

Keywords: Aurinia Pharmaceuticals, Rockville , Senior Manager, Regulatory Affairs, Other , Rockville, Maryland