Regulatory Affairs' Specialist

Partners is looking for a Regulatory Affairs Specialist. Apply today!

The Regulatory Affairs Specialist is responsible for managing and documenting internal regulatory procedures, including but not limited to, conducting internal audits, overseeing inspections, handling license renewals, and managing registrations. This specialist is tasked with gathering and preparing documentation for submissions to regulatory bodies, ensuring that all drug-related products comply with the necessary regulatory standards. With a focus on the pharmaceutical sector, this position requires a meticulous approach to overseeing regulatory compliance and facilitating the effective submission process to regulatory agencies.

Qualifications

• Discretion in handling confidential and sensitive information.

• Knowledge of Good Manufacturing Practices and regulations from the FDA, CMS, and Federal Trade Commission (FTC).

• Understanding of pharmaceutical and cosmetic industry standards.

• Ability to interpret and apply Federal and State regulations to company practices

. • Capable of resolving routine to complex issues, making sound judgments, and escalating matters to senior management when needed.

• Prioritize tasks and manage projects to meet goals and deadlines.

• Apply industry best practices and regulatory knowledge to problem-solving and decision-making.

Essential Responsibilities

• Assist in the preparation and submission of regulatory applications, reports, or correspondence to regulatory agencies.

• Determine necessary regulatory documentation for various scenarios.

• Review submission materials to guarantee timeliness, accuracy, completeness, and adherence to regulatory standards.

• Offer regulatory advice to various departments or project teams on product design, development, evaluation, or marketing.

• Support the formulation and implementation of regulatory affairs policies and procedures to maintain or enhance regulatory compliance.

• Disseminate regulatory information across multiple departments, ensuring accurate interpretation.

• Participate in audits, regulatory agency inspections, and product recalls management

. • Contribute to regulatory strategy and planning for new product submissions.

• Respond to regulatory agencies regarding product information or issues.

• Assist in investigating product complaints, preparing necessary documentation, and submissions to regulatory agencies. • Support the implementation and monitoring of complaint processing systems to ensure effective and timely resolutions.

• Keep abreast of relevant regulations, including proposed and final rules.

• Help maintain technical files to obtain and sustain product approval.

• Prepare and distribute management reports and documentation related to regulatory responsibilities.

• Engage in internal committees and complete special projects as assigned.

• Demonstrate excellent interpersonal skills and professionalism with company management, staff at all levels, vendors, and external agencies.

• Adhere to company policies and procedures, setting a positive example for the organization.

• Prioritize tasks to ensure efficient job completion.