Manager - Regulatory Affairs - CRLB - Mumbai

Job Description

MAIN PURPOSE OF ROLE

Summarize the main purpose of the role.

Specialist professional individual contributor with comprehensive knowledge in the area of Regulatory Affairs.

Ability to execute highly complex or specialized projects.

Adapts precedent and may make significant departures from traditional approaches to develop solutions.

MAIN RESPONSIBILITIES

u2022 As the Specialist in the Regulatory Affairs Sub-Function, considered as highly experienced and knowledgeable resource within the organization 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 Level Major / Field of Study Or Education Level

Associates Degree (u00B1 13 years) u2610

Experience / Background

Experience Experience Details

Minimum 7 years

Skills Required

regulatory liaison, Risk Management, regulatory strategy