Sr Specialist Regulatory Affairs

Job Description

MAIN PURPOSE OF THE ROLE
Experienced professional individual contributor that works under limited supervision.
Applies subject matter knowledge in the area of Regulatory Affairs.
Requires capacity to apply skills/knowledge within the context of specific needs or requirements.

MAIN RESPONSIBILITIES
u2022 As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
u2022 Interacts with regulatory agency to expedite approval of pending registration.
u2022 Serves as regulatory liaison throughout product lifecycle.
u2022 Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
u2022 Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
u2022 Serves as regulatory representative to marketing, research teams and regulatory agencies.
u2022 Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

QUALIFICATIONS
Education
Education LevelMajor/Field of StudyorEquivalent
Associates Degree (u00B1 13 years)
Experience/Background
ExperienceExperience Details
Minimum 1 year