Regulatory Submissions Manager
Company: ICON plc
Location: Bangalore, India (Remote)
Employment Type: Full-Time
Experience Required: Minimum 6 Years
Salary Package
Expected CTC: ₹20 LPA – ₹35 LPA (Estimated market range based on experience, regulatory expertise, and organization. Actual salary may vary.)
Job Summary
ICON is seeking an experienced Regulatory Submissions Manager to lead global regulatory submission activities across various stages of drug development. The role involves providing strategic regulatory guidance, managing Clinical Trial Applications (CTA), Investigational New Drug (IND), and Marketing Authorization Applications (MAA), while ensuring compliance with global regulatory requirements and supporting cross-functional teams.
Key Responsibilities
Lead and manage regulatory submission activities independently across multiple projects.
Prepare, review, and coordinate regulatory submissions, including CTA, IND, and MAA.
Provide regulatory strategy, guidance, and operational support to internal project teams.
Participate in interactions with global regulatory authorities and support regulatory communications.
Ensure submissions comply with global regulatory requirements, guidelines, and applicable health authority expectations.
Collaborate with cross-functional teams, including Clinical Operations, Medical Writing, Pharmacovigilance, Quality Assurance, and Project Management.
Contribute to regulatory planning throughout the drug development lifecycle, from early development through post-approval activities.
Develop and implement best practices to improve regulatory submission processes and operational efficiency.
Monitor changes in global regulatory regulations and ensure organizational compliance.
Support project planning, submission timelines, and risk management activities.
Required Qualifications
Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, or another scientific/healthcare-related discipline.
Master's degree or other advanced qualification is preferred.
Minimum 6 years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, or CRO industry.
Hands-on experience managing global regulatory submissions, including CTA, IND, and MAA.
Experience leading regulatory activities independently.
Required Skills
Strong knowledge of global regulatory requirements and submission guidelines.
Expertise in Clinical Trial Applications (CTA), Investigational New Drug (IND), and Marketing Authorization Applications (MAA).
Regulatory strategy development and submission planning.
Experience interacting with global Health Authorities.
Strong project management and organizational skills.
Excellent written and verbal communication skills.
Ability to lead cross-functional teams and manage multiple regulatory projects.
Strong analytical and problem-solving abilities.
Proficiency in Microsoft Office and regulatory documentation systems.
Preferred Skills
Experience with global regulatory agencies such as FDA, EMA, MHRA, PMDA, Health Canada, and other international Health Authorities.
Knowledge of eCTD publishing and electronic submission processes.
Experience supporting product lifecycle management, including post-approval regulatory activities.
Familiarity with global drug development processes and regulatory intelligence.
Ability to mentor junior regulatory professionals and contribute to process improvement initiatives.
Employee Benefits
Competitive base salary with performance-based incentives.
Comprehensive medical, dental, and vision insurance (where applicable).
Retirement and pension plans.
Life insurance and disability coverage.
Employee Assistance Program (EAP).
Health and wellbeing initiatives.
Structured learning and career development programs.
Flexible remote work environment.
Opportunities to work on global regulatory projects within a leading clinical research organization.
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