Regulatory Affairs Specialist

Overview

Plastikon Healthcare is seeking a detail-oriented and knowledgeable Regulatory Affairs Specialist to join our dynamic team. The ideal candidate will play a crucial role in ensuring that our products comply with all regulatory requirements and standards. This position involves working closely with various departments to facilitate the approval process for new products and maintain compliance for existing ones. The Regulatory Affairs Specialist will be instrumental in navigating the complexities of FDA regulations.

Duties

• Works with the Client to plan and organize registration packages.
• With oversight, serves as liaison with regulatory agencies pertaining to assigned products. Assists in the preparation of agency meeting packages and strategies for agency meetings.
• Evaluates CMC and labeling changes for regulatory impact with guidance. Accurately describes these changes for ease of client and regulatory agency review.
• Support special projects and process improvement initiatives as assigned.
• Reviews and approves documents, seeking guidance when necessary. Reviews and provides input to technical reports for regulatory submission.
• Analyzes, interprets, and summarizes scientific data as well as global regulations.
• Assesses scientific data provided for registration purposes to ensure it meets regulatory requirements.
• Accountable for accuracy of work and meeting deadlines.
• Provides regulatory support to project teams and for maintenance of commercial products with some oversight.
• Successfully supports and executes Client regulatory strategies.
• Makes independent judgments and decisions based on regulations and professional experience, with management oversight as appropriate.
• Track changes and conduct gap assessments for USP, ISPE, ICH, ISO, PDA, and other guidance document or publication updates that may impact our operations.
• Other duties as assigned.

Knowledge, Skills & Qualifications

• Three to five years of pharmaceutical industry experience with a minimum of two years in Regulatory Affairs preferred.
• Emerging knowledge of applicable portions of agency regulations and guidance documents.
• Able to follow scientific arguments.
• Good oral and written communication skills.
• Good interpersonal skills.
• Developing negotiating skills and understanding of business needs.

ESSENTIAL FUNCTIONS

Reasonable Accommodations Statement

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

POSITION QUALIFICATIONS

SKILLS & ABILITIES

• Bachelor’s degree in a scientific field from an accredited college or university is required.
• Pharmaceutical experience, or a related field, that will assist with providing guidance to technical teams, technical writing, and in problem solving technical issues as they relate to product development, manufacture and global registrations.

LANGUAGE SKILLS

Required reading, writing, and speaking fluently in English.

PHYSICAL DEMANDS

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is required to sit, stand, walk, reach with arms and hands, lift objects, and use their hands and fingers to handle or feel. The employee is occasionally required to climb or balance, stoop, and kneel, crouch or crawl. Visions abilities required by the job include close vision. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Join us in making a difference by ensuring that our products meet the highest standards of safety and efficacy. Your expertise will help us navigate the regulatory landscape effectively while contributing to innovative solutions in healthcare.