Senior Regulatory Affairs Consultant Ii (future Opportunities)
Syner-G BioPharma Group
Bengaluru, India
On-site
Cmc post-approval submissions
Fda, ema, global regulatory requirements
Authoring and review of cmc sections
Syner-G enables people to build careers that positively impact quality of life by accelerating breakthrough science and delivery of life-enhancing therapies
Job Summary
Syner-G enables people to build careers that positively impact quality of life by accelerating breakthrough science and delivery of life-enhancing therapies.
The role involves providing regulatory consulting to a global pharmaceutical client, focusing on Chemistry, Manufacturing, and Controls (CMC) for post-approval products.
The company fosters a culture of growth, learning, and rewards, evidenced by multiple 'Best Places to Work' awards.
Matching Summary
Syner-G enables people to build careers that positively impact quality of life by accelerating breakthrough science and delivery of life-enhancing therapies.
Skills & Requirements
Must-have
CMC post-approval submissions
FDA, EMA, global regulatory requirements
authoring and review of CMC sections
US, European regulations and ICH guidances
pharmaceutical development, specifications, release and stability
Nice-to-have
strong ownership and initiative
strategic discussions and decision-making
leadership potential in multicultural settings
cGMP environment experience
regulatory systems and tools experience
Key Requirements
Bachelor’s or Master’s degree
Minimum seven (7) years of CMC post approval submissions experience
Minimum 5 years’ experience in post approval CMC authoring and review