About Harrow Health
Harrow Health, Inc. (NASDAQ: HROW) is an eye health pharmaceutical company focused on the development, production, sale, and distribution of innovative ophthalmic prescription medications. The Harrow platform is designed to provide both patients and physicians with access to affordable medications.
Job Summary
The VP Regulatory Affairs will be responsible for developing and executing global regulatory strategies designed to obtain regulatory approvals to support the business plan. The position will lead and direct all regulatory affairs activities for the Harrow Health ophthalmic unit including global product registration, and compliance objectives. The VP RA must be able to collaborate effectively with R&D, Marketing, Clinical, Medical Affairs, Legal and other functional areas and provide his/her regulatory expertise to effectively develop regulatory strategies that successfully lead products through the FDA clearance/ approval process, as well as other global regulatory agencies.
Location: Nashville, TN Preferred, Ledgewood, NJ and Carlsbad, CA will be considered for the right candidate.
Responsibilities:
· Work closely with the executive leadership team to lead the development of regulatory strategies and objectives that result in the successful registration and post-approval commercialization of Harrow Health’s ophthalmic products.
· Oversee all regulatory matters connected to Harrow Health’s suite of 503A and 503B compounded ophthalmic drug formulation, including supervising the development of all marketing materials
· Develop, lead, and drive the execution of the regulatory strategy from pre-IND to launch, commercialization and product lifecycle management
· Build and lead the Regulatory function including hiring, managing, and developing the Regulatory team
· Plan and oversee activities in support of all regulatory submissions
· Serve as the primary company contact with the US FDA to achieve company regulatory objectives, by fostering strong relationships and acting as a credible, reputable, and effective advocate for Harrow Health.
· Provide regulatory guidance to company personnel across all areas of regulatory affairs throughout all stages from product development
· Develop robust regulatory structures, processes and procedures, and budget forecasting based on expert understanding, industry experience, and insight into the future direction of regulatory policy.
· Monitors US regulatory landscape for changes in policy, regulation, or guidance affecting ophthalmic products and works with management to analyze changes to the regulatory landscape, determine any internal impact, and communicate and provide guidance to all impacted key stakeholders.
Qualifications:
· Minimum Bachelor’s degree required
· Minimum of 15 years of relevant regulatory strategy experience in pharmaceutical industry
· Strong working knowledge in ophthalmic products
· Prior experience with face-to-face interactions with US FDA
· Experience with CTD format and content for regulatory filings
· Demonstrated ability to influence others and foster team collaboration
· Excellent written and verbal communication skills
· Proven ability to prioritize and meet critical business timelines
· Experience with launching new products or new indication
· Familiar with Veeva platform regulatory dossier capabilities
This is a full-time position working Monday through Friday. Occasional overtime and evening hours and/or weekends may be required as per business needs.
AAP/EEO Statement
Harrow believes in creating long-term relationships by being responsive and relevant and by consistently delivering value to our community of customers. Specifically, with our employees, we focus on attracting, developing and retaining the best talent for our business, challenging our people, demonstrating a “can-do” attitude and fostering a collaborative and mutually supportive environment.
Diversity creates a healthier atmosphere: All qualified applicants will receive consideration for employment without regard to age, ancestry, race, color, religion, sex, national origin, protected veteran status, disability status, marital status, medical condition, genetic information, national origin, gender (including gender identity and expression), or sexual orientation.
Harrow is a drug-free workplace. Candidates are required to pass a drug test before beginning employment. In addition, employees in certain positions are subject to random drug testing.
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