Senior Regulatory Affairs Associate
Are you a skilled professional interested in providing device regulatory strategy? Are you interested in playing a key role in growth and project management? If you answered "Yes" to these questions, I have the perfect opportunity for you!
My client, a multi-national pharmaceutical company that develops and produces medicines and vaccines for a wide range of medical disciplines, including immunology, oncology, cardiology, endocrinology, and neurology, is actively searching for a Sr. Regulatory Affairs Associate to join its team in Lake Forest, Illinois. This will be structured as a 12 month contract-to-hire and pay is based on level of prior experience. The Sr. Regulatory Affairs Associate will provide regulatory advice and support to assigned products and/or teams and maintain awareness of applicable regulations.
Among others, this role will take on the following responsibilities:
- Provides regulatory affairs support by preparing labeling and supplements for FDA drug dossiers for new product presentations or lifecycle changes. May be part of a DHF remediation project team. Will be a team member for some project teams, once proﬁcient will take the lead role.
- Identiﬁes and communicates regulatory needs and strategies, considering both drug and device regulations.
- Prepares pharmaceutical submission supplements that meet FDA regulatory requirements and guidelines.
The best candidates for this role will possess the following basic qualifications:
- Bachelor's degree in pharmacy, biology, chemistry, engineering, or a related subject, Master's Degree is preferred
- 5 years of Regulatory Affairs experience within the medical device or combination products industries
- Strong experience with design history file and design control
- Experience drafting or writing applications such as 510(k), PMAs, INDA, NDA, ANDA, etc.
The Sr. Regulatory Affairs Associate is an outstanding opportunity to take on collaborative position and grow within a top notch organization, and Lake Forest, IL is a fantastic location!
If you are interested in learning more and/or applying, please reach out to me on the details below!
Sthree US is acting as an Employment Business in relation to this vacancy.