Regulatory Affairs Senior Associate

Senior Associate - Regulatory Affairs, Oncology

At ***, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. *** is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the *** team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that client within them, you'll thrive as part of the *** team. Join us and transform the lives of patients while transforming your career.

What you will do:

• Assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization.
• Coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead in compliance with corporate standards and regulatory requirements.
• Manage and execute the preparation, delivery, and electronic archiving of documentation for inclusion in US regulatory submissions.
• Assist the Global Regulatory Lead to manage GRT interactions.

Key responsibilities include:

• Assist US Regulatory Lead to support local regulatory activities (e.g. IND submissions and agency meetings)
• Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with US Regulatory Lead
• Create and maintain product regulatory information and history documents through *** systems
• Appropriately archive regulatory documents and agency communications
• Collaborate with CRO's / partners to support site initiation
• Complete regulatory forms to support agency communications
• Participate in GRT to support execution of regulatory strategy
• Coordinate QC of regulatory documentation (e.g. briefing materials)
• Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
• Assist in template development and maintenance
• Respond to specific requests from and communicate relevant issues to GRT
• Actively support regulatory compliance

What we expect of you:

The dynamic professional we seek is a self-starter with these qualifications:

• Master's degree Or Bachelor's degree and 2 years of Regulatory Affairs experience Or Associate's degree and 6 years of Regulatory Affairs experience Or High school diploma / GED and 8 years of Regulatory Affairs experience
• Strong communication skills - both oral and written
• Ability to understand and communicate scientific/clinical information
• Ability to collaborate with team members to tackle problems and develop a course of action
• Cultural awareness and sensitivity to achieve global results
• Planning and organizing abilities
• Able to prioritize and balance multiple activities
• Ability to deal with ambiguity
• Ability to influence others