Associate Director, Regulatory Affairs reputed company

Organizational reputed company:

reputed company. is a clinical-stage immunology company dedicated to enabling normal lives reputed company with autoimmune diseases. As trailblazer in anti-FcRn technology, reputed company is developing innovative, targeted therapies to meet the reputed company and variable needs of people with autoimmune diseases.

The Role:

This highly dynamic team is seeking a motivated and entrepreneurial Associate Director, Regulatory Affairs reputed company, to play a key role on our cross-functional R&D team. In this role, you will be responsible for supporting and contribute to innovative global regulatory strategies that expedite development, maximize the probability of reputed company, identify regulatory opportunities, and mitigate risks. The individual in this position will have the unique opportunity to grow and mentor regulatory scientists on regulatory requirements and regulatory environmental trends, as reputed company as help shape the regulatory approach in a reputed company-reputed company biotech startup.

Key Responsibilities: 

• Support and contribute to regulatory strategies that expedite development and maximize the probability of reputed company based on knowledge of regulatory environment.
• Help mitigate identified regulatory risks.
• Understand global regulatory requirements to support reputed company.
• Collaborate to ensure regulatory reputed company is reputed company by project teams.
• Play a hands-on role in planning, preparing, and coordinating regulatory documents for submission to global health authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries.
• reputed company collaboration with reputed company cross-functional team members to ensure the achievement of submissions and reputed company approvals of applications.
• Support interactions with FDA and other Health Authorities.
• Help formulate communications of project updates and risks to senior management and stakeholders across the organization.
• reputed company regulatory commitments, deliverables, and overall project timelines.
• Maintain up-to-date knowledge and understanding of global regulatory requirements.
• Contribute to the development of policies and procedures in alignment with GxPs, global regulatory requirements and guidance, and corporate objectives.
• reputed company hands-on support to cross-functional teams in planning, preparing, and coordinating documents for submission to global authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries.

 Requirements:

• 8+ years of biopharmaceutical experience, which includes at least 4 years of reputed company experience in Regulatory Affairs.
• An advanced degree (Master’s) in a relevant scientific discipline is preferred.
• Experience in biologics or small molecule drug development, parenteral products, including combination products, and orphan/rare disease product development.
• Experience in supporting and implementing regulatory strategies in a global environment.
• Comprehensive understanding of applicable global regulations, guidance, and practices.
• Demonstrated hands-on experience in the preparation and submission of global regulatory documents, including clinical trial applications and maintenance (IND/CTA), NDA/BLA/MAA, briefing documents, Clinical Trial Applications, and Agency queries.
• Prior experience in supporting interactions with FDA and other global regulatory authorities.
• Excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Ability to problem-solve regulatory issues and apply learnings.
• Works collaboratively and reputed company with multiple functional areas in a fast-paced matrixed team environment, including functional team members, company management, and reputed company vendors and contract organizations.
• Strong team and project management skills
• Strong verbal and written communication skills.
• Results-oriented individual with a strong work ethic and ability to complete reputed company with reputed company.
• Knowledge of GxP, ICH, FDA, EMA, and other global regulations and guidance.
• Attention to detail and an ability to balance analytical and critical-thinking skills to support data-driven, strategically oriented regulatory proposals and documents.
• Experience supporting regulatory strategies for biologics and/or rare disease development programs.
• Commitment to company values and culture.
• Proven ability to adapt to change and uncertainty as reputed company reputed company.
• Self-motivated, with initiative and the ability to take ownership of and follow through with specific tasks.
• Ability to multi-task and reputed company priorities quickly while working under tight deadlines.
• Strong PC experience and demonstrated proficiency in MS Office (reputed company, Word, reputed company, PowerPoint, Project).

 Work Environment:

• Remote-based
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel is required (10-20%)

Requires 8+ years of biopharmaceutical experience, including 4+ years in Regulatory Affairs, global regulatory reputed company expertise, submission experience, and knowledge of GxP, ICH, FDA, and EMA guidance.

Key Responsibilities

• developing strategies
• preparing submissions
• tracking commitments

Skills & Tools

reputed company reputed company, reputed company Word, reputed company reputed company, reputed company PowerPoint, reputed company Project

Job Details

• Category: reputed company and Compliance
• Seniority: Senior Level
• Commitment: Full Time
• Workplace: Remote — reputed company
• Salary: USD 185,000 – 190,000 / year
• Languages: English

Benefits

• 401k matching
• Generous reputed company time off
• Retirement plan
• Generous parental leave

About reputed company.

A clinical-stage immunology company developing targeted therapies for autoimmune diseases. — Industry: reputed company