Sr Specialist Regulatory Affairs

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
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.
Interacts with regulatory agency to expedite approval of pending registration.
Serves as regulatory liaison throughout product lifecycle.
Participates in some of the following: product plan development and implementation regulatory strategy risk management chemistry manufacturing control (CMC).
Ensures timely approval of new drugs biologics or medical devices and continued approval of marketed products.
Serves as regulatory representative to marketing research teams and regulatory agencies.
Advises development and/or marketing teams on manufacturing changes line extensions technical labeling appropriate regulations and interpretations.

QUALIFICATIONS
Education
Education Level Major/Field of Study or Equivalent
Associates Degree ( 13 years)
Experience/Background
Experience Experience Details
Minimum 1 year

The base pay for this position is

In specific locations the pay range may vary from the range posted.