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Experienced Senior Manager – Regulatory Affairs – Biologics responsible for leading global regulatory strategies, biologics submissions, and compliance activities for biopharmaceutical products. Skilled in managing regulatory dossiers, health authority interactions, lifecycle management, and compliance with international biologics regulations. Adept at collaborating with cross-functional teams to support product development, approvals, post-approval changes, and regulatory risk management while ensuring timely submissions and sustained regulatory compliance.
Roles & Responsibilities
- Lead regulatory affairs activities for biologics and biopharmaceutical product portfolios.
- Develop and execute global regulatory strategies aligned with business and product development goals.
- Prepare, review, and submit regulatory dossiers including IND, BLA, CTD, and related submissions.
- Ensure compliance with international regulatory guidelines and biologics-specific requirements.
- Coordinate with R&D, clinical, manufacturing, quality, and analytical teams for regulatory documentation.
- Manage lifecycle maintenance activities including variations, renewals, supplements, and change controls.
- Support interactions and communications with health authorities and regulatory agencies.
- Review technical documents related to biologics manufacturing, characterization, stability, and quality systems.
- Monitor evolving global biologics regulations and assess impact on ongoing projects.
- Lead responses to regulatory queries, deficiency letters, and inspection observations.
- Support regulatory intelligence activities and provide strategic guidance to internal stakeholders.
- Participate in audits, inspections, and compliance assessments related to biologics products.
- Ensure accurate maintenance of regulatory databases, submission trackers, and documentation records.
- Drive process improvement initiatives to enhance regulatory efficiency and submission quality.
- Mentor and guide regulatory affairs teams on biologics regulations, compliance standards, and best practices.
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About Sun Pharma
Sun Pharmaceutical Industries is one of the world’s leading specialty generic pharmaceutical companies. Founded in 1983, the company provides high-quality and affordable medicines to patients in more than 100 countries. With a strong global presence, Sun Pharma focuses on innovation, healthcare accessibility, and patient care.
The company has grown into the No.1 pharmaceutical company in India and continues to expand across international markets through advanced research, modern manufacturing facilities, and a diversified product portfolio.
Quick Facts
- Founded: 1983
- Global Revenue: US$ 6.2 Billion
- Employees: 43,000+ worldwide
- Manufacturing Facilities: 41
- Countries Served: 100+
- India Ranking: No.1 Pharmaceutical Company
Vision
“Reaching People and Touching Lives Globally as a Leading Provider of Valued Medicines.”
Sun Pharma aims to improve healthcare access by delivering trusted medicines and innovative healthcare solutions worldwide.
What Sun Pharma Does
Sun Pharma manufactures and markets a wide range of pharmaceutical products, including:
- Generic medicines
- Specialty medicines
- Branded generics
- OTC (Over-the-Counter) products
- Active Pharmaceutical Ingredients (API)
- Complex and innovative drug formulations
The company develops medicines across several therapeutic areas such as:
- Cardiology
- Dermatology
- Oncology
- Neurology
- Gastroenterology
- Respiratory care
- Diabetology
- Ophthalmology
- Urology
Innovation & Research
Sun Pharma is known for its strong focus on research and development (R&D). The company invests approximately 6–8% of its annual global revenue into innovation and product development.
R&D Highlights
- 2,900+ R&D professionals
- Advanced formulation and analytical development
- Expertise in complex products like:
- Inhalers
- Liposomal drugs
- Nasal sprays
- Controlled-release medicines
- Lyophilized injections
Global Presence
Sun Pharma has established a strong footprint across:
- India
- United States
- Brazil
- Mexico
- Russia
- South Africa
- Canada
- Australia
- Japan
- Europe
The company is also among the leading specialty generic companies in the U.S. market.
Employees & Work Culture
Employee Strength
Sun Pharma employs more than 43,000 people globally from diverse cultural and professional backgrounds. The company believes in empowering employees, encouraging innovation, and supporting personal and professional growth.
Employee Promise – “Create Your Own Sunshine”
Sun Pharma encourages employees to take initiative, learn continuously, and grow together. The company’s employee culture is built on three pillars:
Better Everyday
- Continuous learning and improvement
- Skill development opportunities
- Performance-driven environment
Take Charge
- Leadership opportunities
- Employee empowerment
- Ownership and accountability
Thrive Together
- Team collaboration
- Diversity and inclusion
- Respect and mutual support
Company Culture – Sunology
Sun Pharma follows a workplace philosophy called Sunology, which represents the company’s values and way of life.
Core Values
- Humility
- Integrity
- Passion
- Innovation
- Quality
- Reliability
- Trust
- Consistency
These values help create a positive, ethical, and growth-oriented work environment for employees across the globe.
Code of Conduct
Sun Pharma follows a strong global code of conduct to maintain:
- Ethical business practices
- Transparency
- Employee responsibility
- Patient-focused healthcare standards
- Compliance with international regulations
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