Enable America Jobs

Title: Manager/Senior Manager US Regulatory Affairs - Global Development Projects

Location: Remote

Type: Contract

Rate: 52-70 (DOE)

Start Date: ASAP

Leading Pharmaceutical Company located in NJ is hiring a Manager/Senior Manager US Regulatory Affairs - Global Development Projects with 5+ years industry experience. If you want to be a part of this groundbreaking work, please apply!

Responsibilities:

• Provide regulatory strategy and tactical support for assigned projects.

• Contribute to developing global/regional regulatory strategies for multiple clinical development projects at all stages (Pre-IND through NDA submission and approval).

• Support and perform with limited oversight larger submissions, such as IND applications and NDAs, including organizing the submission development and review process and timeline, preparing sections, reviewing for completeness, accuracy, and appropriateness.

  Minimum Requirements:

• Bachelor’s degree in science (e.g. Chemistry, Pharmacy, Biochemistry). Master’s degree in science related field strongly preferred.

• Minimum of 6 years of pharmaceutical industry experience with at least 4 of those years in Clinical Development Operations and Regulatory positions.

• Working knowledge and experience in regulatory submissions and product life cycle management.

• Broad range of experience to include Pre-IND and Phase I clinical development through NDA filing is sought (though not necessarily with same compound).

• Knowledge of drug regulations and guidance’s with ability to apply them to complex regulatory issues and requirements.

• Ability to simultaneously plan, coordinate and lead activities on multiple projects.

• Ability to self-direct workload, including reprioritizing and delivery under tight timelines.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services 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 full-time 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.