Regulatory Affairs Manager
Rockville, Maryland
Experience: 0
Category: Scientific & Clinical
Brand: Joulé
Job ID: 315963
Date Posted: 02/21/2024
Shortcut: http://jobs.systemone.com/l83GdR
Title: Regulatory Affairs Manager
Location: Remote
Type: Permanent
Salary: 120K – 140K plus 10-20% discretionary bonus
Requirements
- Bachelor's degree in life sciences or related field; advanced degree preferred.
- Minimum of 3-5 years of experience in operational regulatory affairs within the biotech, preferably in oncology.
- Writing Canadian and US submissions (BGTD experience)
- eCTD experience required (package used is off the shelf product)
- Strong knowledge of global regulatory requirements and guidelines for drug development.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
- Proven ability to manage multiple projects simultaneously and meet tight deadlines.
- Detail-oriented with a strategic mindset and problem-solving skills.
Responsibilities
- Develop and implement regulatory strategies to support the development and commercialization of oncology products.
- Prepare and submit regulatory submissions to health authorities, including INDs, CTAs, NDAs, and marketing applications.
- Coordinate and liaise with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.
- Keep abreast of regulatory changes and updates relevant to the oncology industry, providing guidance to internal stakeholders.
- Represent the company in interactions with regulatory agencies and support regulatory inspections and audits.
- Manage regulatory documentation and maintain compliance with applicable regulations and standards.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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