Job Description
MAIN PURPOSE OF ROLE
• Leads/supervises a team of more than 2 professionals within the Regulatory Affairs Sub-Function.
• First level manager of a work team that may comprise professionals, technical and/or administrative staff.
• Typically without budget or hire/fire authority.
• Focuses on mentoring, coaching, and coordination.
MAIN RESPONSIBILITIES
• As the Team Leader (Professionals) of the Regulatory Affairs Sub-Function, supervises professionals 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
Education Level
Associates Degree (± 13 years)
☐
Experience/Background
Experience
Experience Details
Minimum 4 years
• Leads/supervises a team of more than 2 professionals within the Regulatory Affairs Sub-Function.
• First level manager of a work team that may comprise professionals, technical and/or administrative staff.
• Typically without budget or hire/fire authority.
• Focuses on mentoring, coaching, and coordination.
MAIN RESPONSIBILITIES
• As the Team Leader (Professionals) of the Regulatory Affairs Sub-Function, supervises professionals 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
Education Level
Associates Degree (± 13 years)
☐
Experience/Background
Experience
Experience Details
Minimum 4 years
💡 Quick Summary
Seeking a career-building opportunity? The CMC Manager position is now open for candidates interested in the IT Engineer & Developer Jobs sector. This role in India offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in IT Engineer & Developer Jobs is a plus.
