
Senior Regulatory Affairs Specialist
3 weeks ago
We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team. In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products.
RESPONSIBILITIES:
• Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements
• Provide regulatory direction on global regulatory requirements to support product development
• Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle
• Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration
• Ensure and lead regulatory compliance for biosimilar products
• Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products
• Escalate regulatory issues, progress, and metrics to the GRA Biosimilars function
KNOWLEDGE AND SKILLS
• Comprehensive understanding of Regulatory activities
• Experienced in analytical method development, method validation, method transfers and characterization of biologic products. Regulatory experience with product filings
• Ability to understand and communicate scientific CMC information
• Anticipate and prevent potential issues
• Ability to communicate regulatory strategies and requirements to ensure expectations are understood
-
Senior Regulatory Affairs Specialist
15 hours ago
Ghaziabad, Uttar Pradesh, India beBeeGovernment Full time ₹ 15,82,500 - ₹ 25,17,500Job Title: Senior Regulatory Affairs SpecialistWe are seeking a seasoned professional to build and maintain relationships with government officials and regulatory bodies, ensuring our company's compliance with relevant laws and regulations. This role requires strong communication, negotiation, and relationship-building skills, as well as a deep understanding...
-
Medical Device Regulatory Professional
1 day ago
Ghaziabad, Uttar Pradesh, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000**Regulatory Affairs Specialist: Secure Global Product Compliance**We are seeking an experienced Regulatory Affairs professional with a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.Key Responsibilities:Prepared, reviewed, and...
-
Senior Medical Device Compliance Expert
6 hours ago
Ghaziabad, Uttar Pradesh, India beBeeQuality Full time ₹ 20,00,000 - ₹ 25,00,000Job Title: Executive Quality Assurance and Regulatory Affairs Specialist"],
-
Senior Compliance Specialist
7 days ago
Ghaziabad, Uttar Pradesh, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000Regulatory Affairs ProfessionalThe ideal candidate for this role will have a strong understanding of ICH, USFDA guidelines and regulatory frameworks applicable to generic drug products. They will lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation review and filing.
-
Senior Compliance Professional
1 day ago
Ghaziabad, Uttar Pradesh, India beBeeCompliance Full time ₹ 1,80,00,000 - ₹ 2,40,00,000Job DescriptionThe Compliance Officer is a vital role within our organization, responsible for ensuring adherence to regulatory requirements and promoting a culture of compliance.Key ResponsibilitiesRegulatory Monitoring & Implementation:Track and evaluate relevant regulatory updates, assessing their impact on policies and business processes.Disseminate...
-
Senior Compliance Specialist
1 day ago
Ghaziabad, Uttar Pradesh, India beBeeCompliance Full time ₹ 20,00,000 - ₹ 25,00,000Senior Compliance SpecialistWe are seeking a seasoned Quality Assurance professional to join our team as a Senior Compliance Specialist. The ideal candidate will have a strong background in pharmaceutical quality assurance, regulatory compliance, and auditing.Develop, implement, and maintain quality systems and procedures to ensure compliance with cGMP...
-
Financial Regulatory Expert
1 day ago
Ghaziabad, Uttar Pradesh, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,10,00,000We are seeking talented individuals to fill the position of Assistant Vice President in our Financial Regulatory Practice.This senior role demands a strong regulatory mindset, experience with large and diverse portfolios, and demonstrated capability to interpret evolving supervisory expectations, institutional frameworks, and global best practices with...
-
Senior Corporate Financial Strategist
1 day ago
Ghaziabad, Uttar Pradesh, India beBeeStrategic Full time ₹ 40,00,000 - ₹ 45,00,000Strategic Financial Leadership OpportunityWe are seeking an experienced and results-driven Chief Financial Officer (CFO) to lead our company's financial strategy and planning.Key Responsibilities:Develop and execute comprehensive financial strategies aligned with business objectives.Lead annual budgeting, forecasting, and financial planning cycles to ensure...
-
Regulatory Change Monitoring Specialist
2 days ago
Ghaziabad, Uttar Pradesh, India beBeeRegulatory Full time ₹ 18,07,500 - ₹ 25,15,015We are seeking experienced professionals to support the design and deployment of an AI-driven Regulatory Horizon Scanning solution.This role focuses on leveraging Artificial Intelligence (AI), Natural Language Processing (NLP), and advanced analytics to automatically monitor, interpret, and analyse regulatory updates across multiple jurisdictions.Key...
-
Business Risk Specialist Position
1 day ago
Ghaziabad, Uttar Pradesh, India beBeeRisk Full time ₹ 2,00,00,000 - ₹ 3,00,00,000Business Risk SpecialistJob Title: Business Risk SpecialistKey Responsibilities: Identify, assess and mitigate market, credit, operational, liquidity and regulatory risks by implementing risk strategies.Evaluate investment portfolios to assess exposure to various risk factors.Risk Management Strategies:Implement risk mitigation strategies and support in...