****Remote, must be based in the US. Must be flexible to work based on business needs. 8-5***
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
In this vital role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization.
To coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead in compliance with corporate standards and regulatory requirements.
To manage and execute the preparation, delivery, and electronic archiving of documentation for inclusion in US regulatory submissions
To 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
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a self-starter with these qualifications.
Basic 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
Preferred Qualifications:
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