Associate Manager – CMC Regulatory

Growth For Impact; Bengaluru; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Growth For Impact is seeking a CMC Regulatory Affairs professional to design and develop regulatory strategy for marketed products, balancing creativity, business benefit, and compliance. You will lead CMC submission preparation to deliver high-quality filings across multiple geographies and ensure documentation, content quality and timelines are communicated to cross-functional teams.

Keep knowledge up to date with global regulatory guidelines and trends; provide mentorship to CMC team members

Qualifications

• 5+ years of experience in Global Regulatory Affairs, preferably in post‑approval CMC Life Cycle Management.
• Strong knowledge of FDA/CVM, EMA, and VICH guidelines.
• Experience with CMC registrations in the US, Europe, and/or Rest of the World.
• Experience managing multiple pharmaceutical dosage forms.
• Strong written and oral communication skills.
• Ability to make decisions in ambiguous situations.
• Self‑starter with initiative; timeline‑driven; attention to detail.
• Quality and customer‑focused mindset.
• Strong organizational skills; ability to handle multiple projects at different development phases simultaneously.
• Understanding of cGMP requirements.
• Experience with Regulatory Information Management Tools and Systems.

Responsibilities

• Design and develop regulatory strategy for CMC across geographies.
• Lead CMC submission preparation to deliver high-quality submissions.
• Proactively communicate CMC regulatory strategy and issues to interdisciplinary teams.
• Ensure documentation, content quality, and timelines for global submissions are tracked.
• Author high-quality CMC documentation for submission.
• Keep knowledge up to date with regulatory guidelines and trends.
• Provide training and mentorship to CMC team members.

Skills

Global regulatory affairs

Regulatory strategy

CMC documentation

Project management

Communication skills

Attention to detail

Decision making

Tools

RIM tools

Job description

ROLE

• Design and develop CMC regulatory strategy for marketed products, balancing creativity, business benefit, and regulatory compliance.
• Lead CMC submission preparation to deliver high‑quality submissions to multiple geographies.
• Proactively communicate CMC regulatory strategy, key issues, and critical topics throughout the product life cycle to interdisciplinary project teams, applying global strategy to submissions.
• Ensure required documentation, content quality, and timelines for global submissions are communicated to appropriate teams and tracked per functional procedures.
• Author high‑quality CMC documentation for submission, applying global regulatory strategies and assuring compliance.
• Keep knowledge up to date with regulatory guidelines and requirements in all global regions and new technical trends.
• Provide training and mentorship to CMC team members as necessary.

REQUIREMENTS

• 5+ years of experience in Global Regulatory Affairs, preferably in post‑approval CMC Life Cycle Management.
• Strong knowledge of FDA/CVM, EMA, and VICH guidelines.
• Experience with CMC registrations in the US, Europe, and/or Rest of the World.
• Experience managing multiple pharmaceutical dosage forms.
• Strong written and oral communication skills.
• Ability to make decisions in ambiguous situations.
• Self‑starter with initiative; timeline‑driven; attention to detail.
• Quality and customer‑focused mindset.
• Strong organizational skills; ability to handle multiple projects at different development phases simultaneously.
• Understanding of cGMP requirements.
• Experience with Regulatory Information Management Tools and Systems.