Senior Regulatory Affairs Manager
Are you a skilled professional interested in leading multiple project relating to combination products? 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 Manager 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 Manager will act as the regulatory core team member for, and provides regulatory guidance to combination product project teams in a fast paced, highly visible, complex, and at times ambiguous and changeable environment
Among others, this role will take on the following responsibilities:
- Provides guidance on drug and device regulations, regulatory strategy, and pharmaceutical and design controls/design history ﬁle deliverables to other combination product regulatory professionals.
- Responsible for the creation of all submission documentation for a project with a large portfolio of products; including correspondence, meeting requests and dossier content, including labelling.
- Set and communicate timelines for the regulatory submissions and for the delivery of supporting documentation. Ability to work with all functional areas to obtain needed information on time.
The best candidates for this role will possess the following basic qualifications:
- B.S. or higher in Science or related field, Master's Degree is preferred
- Minimum of 8 years of Regulatory Affairs experience within the medical device or combination products industries
- Strong experience with design history file and design control
- Experience leading a project team to provide regulatory approval, regulatory strategy, and leading core team meetings
- Experience drafting or writing applications such as 510(k), PMAs, INDA, NDA, ANDA, etc.
The Sr. Regulatory Affairs Manager 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.