Regulatory Affairs Consultant
Company: Parexel
Location: India (Fully Remote)
Job Type: Full-Time (Consulting Role)
Experience: Typically 7–10 Years (Regulatory Affairs – LCM & CMC)
Qualification: Bachelor’s in Science / Pharma (Advanced Degree Preferred)
Salary Range: Not Specified
Parexel is hiring a Regulatory Affairs Consultant—a role that goes beyond internal company work and moves into client-facing regulatory strategy and consulting.
You’ll work with multiple pharma/biotech clients globally, helping them navigate regulatory pathways, fix gaps, and accelerate approvals.
👉 This is not just execution. This is advisory + strategy + exposure across companies.
Handle post-approval regulatory activities across US, EU, Japan, Canada, etc.
Manage variations, renewals, expansions, and site transfers.
Evaluate change controls and regulatory impact.
Develop gap analysis + remediation plans for submissions.
Advise clients on regulatory pathways for IND, NDA, BLA, MAA, DMF.
Guide strategy across global markets.
👉 This is where you stop being “employee” and start acting like advisor.
Author and review CMC sections of submissions.
Respond to Health Authority queries.
Handle complex CMC regulatory challenges.
Plan, prepare, and deliver regulatory submissions.
Work on EU procedures (DCP, MRP, National).
Ensure compliance with global regulatory frameworks.
Coordinate with internal + external stakeholders.
Identify quality/timeline risks early.
Mentor junior team members.
Stay updated with evolving global regulations.
Apply new guidelines to ongoing submissions.
Strong experience in LCM + CMC regulatory work
Knowledge of global regulations (US, EU, Japan, Canada, etc.)
Experience with submission types (IND, NDA, BLA, MAA, DMF)
Ability to perform gap analysis + regulatory planning
Strong decision-making capability
Client-facing communication skills
Ability to influence and guide stakeholders
Experience with RIMS tools (e.g., Veeva Vault)
Global regulatory strategy
Consulting mindset
CMC expertise
Lifecycle management ownership
Stakeholder & client handling
Risk assessment & problem-solving
Parexel is a leading CRO and consulting organization that supports pharmaceutical and biotech companies across clinical research, regulatory strategy, and commercialization.
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