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Director of Regulatory Affairs - Flowery Branch, United States - Kiel Laboratories, Inc.
2 weeks ago
Description
Overview:
Kiel Laboratories is a pharmaceutical research and development company located in Flowery Branch, GA. We are searching for an experienced manager responsible for preparing technical documents to support both domestic and international regulatory submissions, market labeling, clinical labeling, troubleshooting guides, training aids, and customer specifications for pharmaceutical products. Incorporates text, graphs, charts, tables, statistical analyses, etc. in a clear and accurate manner and confirms the accuracy thereof.
Essential Duties:
Serves as the Lead Regulatory representative on product teams.
Coordinates all activities related to the preparation and compilation of data and information into a single comprehensive package for new and revised domestic and international regulatory submissions, market labeling, clinical labeling, troubleshooting guides, training aids, and customer communications for pharmaceutical products. Including but not limited to the following:
• Communicates deliverables needed to team members.
• Accesses resource needs as timelines progress and communicates those needs to management.
• Utilizes submission templates (if available) and format/style guidelines established by FDA regulatory requirements.
• Obtains relevant product data and information.
• Assess accuracy of information and understands information sources.
• Converts relevant product data and information into a form that meets submission requirements.
• Reviews, circulates, edits, assembles, inspects, and duplicates product submissions.
• Determines format for submissions and documents.
• Interprets data and verifies that results are consistent with protocols.
• Confirms completeness of information to be presented.
• Confirms label and package insert claims are supported by and consistent with data presented in the submissions.
• Serve as liaison to resolve issues and questions arising during submissions process.
• Arranges and conducts review meetings with teams on submission and related labeling.
• Coordinates responses to inquiries, questions, and deficiencies received from submission reviewers both domestically and internationally.
• Interprets and explains data generated from a variety of sources; including but not limited to – experiments, research documentation, charts, graphs, and tables.
• Explains the data in a manner consistent with the target audience and regulatory requirements
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•May recommend and implement process improvements.
• Draft domestic and international regulatory submissions, market labeling, clinical labeling, troubleshooting guides, training aids, and customer communications for new pharmaceutical products.
• Coordinates activities with product development teams to ensure goals are met.
• Meet quality standards for accuracy and completeness.
• Works independently with minimal supervision.
• Assisted and directed by the Vice President of Research and Development.
Other Duties:
• Possess an in-depth knowledge of the basic and advanced concepts that are related to pharmaceutical development studies.
• Proficiency in in Microsoft Office applications (i.e. Outlook, Word, Excel, PowerPoint, and Access) Superior attention to detail.
•Proficiency in diagrams and flowcharts.
•Excellent verbal and written communication skills, including facilitation of group presentations.
•Ability to critical review personal and team documentation and work for internal/external review.
Supervisory Responsibility:
This position has supervisory responsibilities of managing the day to day activities of those employees responsible for regulatory affairs related content and processes.
Work Environment:
This job operates in both a professional laboratory as well as office/business environment. This role also routinely utilizes standard office equipment and technology such as computers, telephones, photocopiers, and email.
Physical Demands:
The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of this position.
While performing the duties associated with this position, the employee is regularly required to communicate with other staff members and/or outside customers or vendors using both verbal and written communication. The employee will be frequently required to stand, walk, use his/her hands to handle or feel, reach with hands and arms and occasionally lift office products and laboratory supplies, up to 20lbs.
Position Type/Expected Work Hours:
This is a full-time position. Work days and hours are as follows: Monday through Friday, 8:00am – 5:00pm. Over-time and weekends may be required.
Travel Requirements:
Domestic and international travel required.
Educational & Experience Requirements:
Bachelor's degree in scientific, medical, or pharmaceutical field required; Masters degree preferred. Minimum of 5 years professional experience in a related area such as Research & Development, Technical Product Development, Quality, Regulatory Affairs, Clinical Research, or Medical Writing Knowledge of FDA regulations and standards for submissions of pharmaceutical products 1-4 years writing experience as a medical writers in the healthcare industry preferred.
• 1-4 years experience in experimental design and data interpretation preferred.
• 5-10 years of professional experience including demonstrated achievement in business development, sales, and marketing in the pharmaceutical industry.
Please note duties, activities, or responsibilities outlined herein are required for this position and may be subject to change with or without notice.
Kiel Laboratories, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origins, disability status, genetics, protected veteran status, sexual orientation, gender, identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
