Senior Regulatory Affairs Associate

Payrate: $29.00 - $31.00/hr.


Summary:
At Company, you'll be part of a team with a shared mission to serve patients living with serious illnesses. Our focus is on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. We are advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. Join us and transform the lives of patients while transforming your career.


Responsibilities:

• 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.
• Support local regulatory activities such as IND submissions and agency meetings.
• Provide and maintain CTA/MA documentation support in collaboration with the 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.
• Provide primary authorship to routine regulatory correspondence.
• Assist in template development and maintenance.
• Respond to specific requests from and communicate relevant issues to GRT.
• Actively support regulatory compliance.

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.

Skills:

• 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.
• Prior regulatory knowledge experience as a clinical strategist preferred.
• FDA experience is a bonus.

Pay Transparency: The typical base pay for this role across the U.S. is: $29.00 - $31.00 /hour . Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.


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