Senior Regulatory Affairs Associate- CMC Biologics
A free account shows the apply link for every role and matches you to the ones that fit your resume.
About the role
Parexel provides clinical development and consulting services to the life sciences industry. You will manage global regulatory lifecycle activities and prepare CMC submissions and product updates for approved medicines.
What you'll do
- Manage approved product lifecycle activities across global markets
- Prepare and review CMC components of regulatory submissions
- Respond to CMC-related Health Authority queries
- Review DMFs, batch records, specifications, and stability data
- Prepare regulatory impact assessments for product changes
- Maintain submission plans and author labeling content
Skills
Must have
- Regulatory affairs
- Regulatory submissions
- Cmc regulatory affairs
- Post-approval management
- Regulatory impact assessments
- Labeling
- Eu regulatory procedures
- Us regulatory procedures
- Pharmaceutical legislation
Nice to have
- Health authority query responses
- Row regulatory legislation
- Eu qrd template requirements
Tools
- Veeva vault
Who it's for
- Education
- Bachelor's degree
- Degree
- pharmacy, life sciences, chemistry, biotechnology
- Experience
- 5+ years
- Domain
- pharmaceuticals
About Parexel
Parexel has 18 open roles in Bangalore, at Parexel International - RMZ Ecoworld. See every Parexel role.
More at Parexel
Senior · Remote
Manager · On-site
Mid level · 4+ years
Senior · 7+ years
Manager · 11+ years
Manager · 8+ years
Manager · Remote · 9+ years
Mid level · Remote · 3+ years
Similar roles
All legal and compliance jobsGSK (GlaxoSmithKline) · Lead or staff · 8 to 10 years
RTX · Director and above · On-site · 12+ years
Fresenius Medical Care · Lead or staff · Hybrid · 12 to 18 years
Lowe's India (Lowe's Services India Pvt Ltd) · Mid level · On-site · 2 to 3 years
Jones Lang LaSalle (JLL) · Senior · On-site · 5+ years