Regulatory Affairs Specialist

Healthpoint, Ltd. is uniquely committed to the prevention and treatment of diseased and traumatized skin and related soft tissue.  Healthpoint, Ltd. is an operating company of DFB Pharmaceuticals, Inc., a privately owned specialty pharmaceutical company located in Fort Worth, Texas.  Established in 1990 following the purchase of Dermatology Products of Texas (DPT), a San Antonio based pharmaceutical manufacturing firm which began operations in the 1930’s, DFB has grown to over 1,700 employees encompassing three operating divisions.  Through acquisitions paired with organic growth, DFB has become a fully integrated pharmaceutical business with plans for further near-term growth.  The company is segregated into distinct branded pharmaceutical business units (Healthpoint Ltd., tissue management focus; Coria Laboratories Ltd., dermatology focus), and a contract services unit (DPT Laboratories).

 

Research and Development is located adjacent to the company headquarters in Fort Worth, Texas, close to the University of North Texas Health Sciences Center.  Basic and applied research, project management, regulatory affairs, quality, medical and clinical affairs occupy adjacent space and work closely together in a newly constructed 80,000 ft2 facility. 

Sales and marketing activities are enhanced by formal corporate development and training, a responsive Customer Care organization, a dedicated Healthcare Systems group ensuring product availability in all distribution centers, and a professional Clinical Education team that coordinates continuing medical education to practitioners.

By attracting and retaining dynamic and innovative employees, Healthpoint is well positioned to grow its core businesses, pursue strategic business partnerships, and expand its portfolio of products and technologies through dedicated research and NDA development efforts.

 

Healthpoint is currently seeking candidates to fill the following role: Regulatory Affairs Specialist

 

JOB SUMMARY:

 

The Regulatory Affairs Specialist is a key role in regulatory compliance for all commercialized products for the organization.  Reports to Senior Manager, Regulatory Affairs.

 

DUTIES AND RESPONSIBILITIES:

 Coordinates, reviews and assembles various materials for submissions to the FDA including drug product listings, annual reports, FDA Division of Drug Marketing, Advertising & Communications submissions, Adverse Event Reports and Prescription Drug Marketing Act investigation reports.Drafts and maintains applicable policies and procedures to support and define the regulatory affairs function.Assists Regulatory staff in labeling approval process, helping to coordinate the review of all labeling materials and submission of promotional materials to FDA.Reviews and approves all product packaging components.Maintains state registrations and licensesPerforms research for current regulatory requirements pertaining to the pharmaceutical industry.Responsible for handling product and medical inquiriesServes as regulatory representative on cross-functional committees.Assists the Regulatory staff in daily regulatory activities.Establishes and maintains concise files and documentation in support of marketed drugs.Provides regulator information and assistance as requested by internal departments.Performs other tasks and special assignments as assigned by supervisor and superiors.

 

CANDIDATE QUALIFICATIONS, SKILLS, EXPERIENCE & ATTRIBUTES

 Bachelors degree (Required) – preferably in the area of chemistry, biology, or related science.  Paralegal certification is helpful and a plus. 3-5 years experience in pharmaceutical/medical Regulatory Affairs.  Knowledge of the drug, device, and/or biologic development process. Ability to read, analyze, and interpret common scientific and technical journals, reports and legal documents.Able to handle multiple priorities effectively.  Excellent time management skills.Excellent organizational skills.  Must be detail-oriented.  Good communication skills, written and verbal with strong emphasis on writing skills.  Proficient computer skills in MS Office applications, Internet research and Lotus Notes.Must be a team player.