Job Title:
Specialist – Regulatory Affairs Manager
📍 Location: Bangalore, Karnataka, India
🕒 Job Type: Full-time
🔢 Job ID: 291311
Company Overview
We are a global leader in science and technology across Healthcare, Life Science, and Electronics. With a focus on curiosity and innovation, we aim to enrich lives and improve the future through breakthrough solutions. Join us and work your magic alongside passionate professionals from around the world.
Role Summary
As a Regulatory Affairs Manager – Specialist (License Management), you will be responsible for preparing regulatory dossiers and executing actions to support license security and product compliance in global markets. This role requires effective cross-functional collaboration and the ability to manage complex regulatory challenges in a matrix organization.
You will support the license management strategy and ensure regulatory submissions meet company and health authority requirements.
Key Responsibilities
📄 Dossier Preparation & License Management
Prepare and maintain high-quality regulatory submissions (e.g., variations, renewals, and new applications).
Ensure submissions comply with regulatory requirements and timelines.
Execute license management activities that ensure ongoing product compliance.
🤝 Stakeholder Collaboration
Collaborate with global cross-functional teams (e.g., CMC, medical, legal, quality) to align regulatory strategies.
Participate in decision-making processes and facilitate stakeholder alignment.
🌍 Global Regulatory Affairs
Work on life-cycle management (LCM) activities in at least two regions (e.g., Europe, USA; international exposure is a plus).
Maintain knowledge of regional regulatory requirements, post-approval changes, and dossier types.
📑 Documentation & Compliance
Understand and manage supportive documents required for global submissions, such as:
CPPs (Certificate of Pharmaceutical Product)
GMP Certificates
Manufacturing Licenses (MLs)
Authorizations to Operate (AtOs)
Agency Forms (AFs), Cover Letters (CLs), Power of Attorneys (PoAs)
Follow legalization frameworks for country-specific documents.
📅 Project & Risk Management
Adhere to submission timelines, escalating risks proactively.
Contribute to project documentation, progress tracking, and reporting.
Ensure submission readiness and quality of documents.
💻 System Expertise
Use and maintain documentation in Regulatory Information Management (RIM) and Electronic Document Management Systems (EDMS).
Candidate Profile
🎓 Education
Degree in Life Sciences or a related discipline.
Master’s degree (MSc) preferred.
💼 Experience
5+ years of total professional experience in the pharma, regulatory agency, academia, or R&D.
Minimum 1 year of direct Regulatory Affairs experience.
Experience in managing full international submissions and post-approval changes.
🧠 Skills & Competencies
Strong understanding of global regulatory frameworks and documentation standards.
Knowledge of license maintenance, registration documents, and submission planning.
Effective communicator with project management skills.
Proficient in collaboration across a matrix organization.
Experienced user of RA IT systems (RIM, EDMS).
What We Offer
💸 Financial & Savings
Competitive 401(k) plan with company matching and annual discretionary contributions
Tax-advantaged savings accounts
Company-provided and optional life insurance plans
❤️ Health & Wellness
Comprehensive medical, dental, and vision insurance
Telehealth access and free behavioral health counseling
Personalized wellness support and incentives
🏡 Work-Life Support
Generous paid time off
Backup childcare services
Educational assistance
Flexibility and resources for work-life balance
🛍️ Voluntary Perks
Discounts on:
Auto, home, and pet insurance
Personal loans
Travel, wellness, and lifestyle products
Our Recruitment Process
Apply Online
Search and apply for roles matching your profile or join our Talent Zone for future opportunities.
Application Screening
If selected, you’ll proceed to the next stage of evaluation.
Interview & Assessment
Conducted via phone, video, or in-person depending on role and location.
Offer & Onboarding
Once selected, you’ll receive an offer and begin onboarding to work your magic.
Equal Employment Opportunity
We are committed to diversity, equity, and inclusion. All qualified applicants are considered without regard to race, religion, sex, gender identity, age, disability, or any other legally protected characteristics.
If you suspect discrimination, report it through our HR, Legal, or Compliance teams. No retaliation will occur for making a good-faith report.
Important: Job Offer Fraud Alert
⚠️ Be aware of fraudulent job offers. We never ask for money or personal information as part of the recruitment process.
Click here to learn more about fraudulent offers
Apply Now
🔗 Visit our Careers Page
🗂️ Can’t find a fit? Join the Talent Zone to get updates on future roles.
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