Regulatory Affairs specialist

Company : Katalyst Healthcares & Life Sciences

Country: United States

Location : Irving, Texas

Post: Fri, 24 Mar 2023 06:29:32 GMT

Expires: Fri, 21 Apr 2023 23:59:59 GMT

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—————————— Job Description ——————————

Responsibilities:

Develop and implement regulatory strategies to ensure timely product approvals and compliance with all applicable regulations.

Prepare and submit regulatory submissions to regulatory authorities, such as FDA, EMA, Health Canada, and other international regulatory bodies.

Review and approve labeling and promotional materials to ensure compliance with regulatory requirements.

Maintain and update regulatory documentation to ensure accuracy and completeness, including product registrations, technical files, and other regulatory documentation.

Provide regulatory guidance and support to cross-functional teams, including R&D, clinical, and marketing teams.

Participate in regulatory agency meetings, as necessary.

Ensure compliance with all relevant Standard Operating Procedures (SOPs) and regulations.

Requirements:

Bachelor’s degree in a scientific discipline (e.g., biology, chemistry, or related field). A master’s degree is preferred.

5 years of experience in regulatory affairs in the medical industry.

Familiarity with regulations from FDA, EMA, Health Canada, and other international regulatory bodies.

Strong attention to detail and ability to manage multiple projects simultaneously.

Excellent written and verbal communication skills.

Ability to work collaboratively in a team environment.