Regulatory Affairs Manager - Largo, United States - Formulated Solutions

Description

THE COMPANY:

Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience through creativity and invention; delivering our world class Marketing Partners unmatched formulations, innovative packaging and cost effective, reliable supply.

Formulated Solutions is and shall always be a company of people with the knowledge and dedication to provide our Marketing Partners with a single source solution for delivering quality and innovative products to market. We shall embrace changes and new opportunities as a vehicle to continually develop and grow sustainable relationships. As a company we shall never accept anything less than a culture that fosters creativity, growth, and profitability for both our Partners and the company.

MAJOR DUTIES AND RESPONSIBILITIES:

• of Regulatory Compliance activities associated with Formulated Solutions, pre- and post-market of Rx, OTC, Fast Moving Consumer Healthcare, Medical Devices Classes I and II
• regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
• the preparation of regulatory agency applications, reports, submissions, and correspondences for various regulatory agencies (e.g., US FDA, Health Canada, Notified Body, etc.) and maintain site regulatory licenses.
• with Product Development to define US, Canada, EU, and develop global regulatory strategies, requirements, and implementation plans and pathways to market for new/modified products, participate in the development or implementation of clinical trial protocols.
• and maintain standard operating procedures or local working practices, formulate, or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced, train staff in regulatory policies or procedures.
• and support regulatory compliance activities such as audits, regulatory agency inspections, or product recalls. Provide responses to regulatory agencies and customers regarding product information or issues.
• current knowledge of relevant regulations, provide technical, quality, and regulatory compliance intelligence to all sites and businesses, monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
• materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.

Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.

• investigation of product complaints, monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations, prepare documentation and submissions to customers and appropriate regulatory agencies, as necessary.
• documentation efforts to ensure compliance with domestic and international regulations and standards. Establish procedures or systems as needed, for publishing document submissions either in hardcopy or electronic formats.
• regulatory information to multiple departments and ensure that information is interpreted correctly.
• to the development or implementation of business unit strategic and operating plans.
• organizations before domestic or international regulatory agencies on major policy matters or decisions regarding customers and company products.
• regulatory priorities or budgets and allocate resources and workloads.
• in other activities as assigned by the Management.

QUALIFICATIONS:

• ability to manage multiple and diverse projects concurrently.
• ability to develop positive relationships and collaborations.
• analytical skills; a strategic thinker, planner, and implementer.
• dependable, and consistent worker.
• ability to create practical and efficient processes.
• effective interpersonal skills in individual as well as in group settings.
• communication skills, both written and verbal.
• genuine, ethical, fair, and loyal to the organization and its vision and goals.
• able to determine approaches to assignments.
• skills with the ability to analyze situations and/or data while considering future impact and intangible variables.
• attention to detail, accuracy, excellent review and analytical skills in a fast-paced environment.
• perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• accommodations may be made to enable individuals with disabilities to perform the essential functions.
• years of Regulatory Affairs experience in a pharmaceutical, biotechnology, medical device, or related environment.
• understanding of GXP requirements and experience in a regulated industry with focus on FDA, EMA, Health Canada etc.)
• in in the areas of Quality Management Systems, Clinical Quality Assurance, Supplier Quality Management, and External Manufacturing Oversight.
• in data governance, data integrity and General Data Protection Regulation (GDPR).
• to work independently under general direction in a fast-paced environment.
• degree from an accredited four-year college or university in Chemistry, Biology, Physics, Life Science, or Engineering or equivalent experience. Master in Regulatory Affairs preferred.
• to travel up to 10% (domestic and international).

CRITICAL SKILLS AND ABILITIES:

Ability to use a personal computer and measuring devices.

Attentive to detail, thorough and accurate.

Ability to establish priorities, work independently, productively, and proceed with objectives without supervision.

Ability to perform effectively under conditions of fluctuating workload.

Ability to handle and resolve recurring problems.

Communicate with others clearly and concisely.

Ability to work in a fast-paced environment – sometimes rapidly shifting priorities. Ability to concentrate in such an environment and perform quality work.