Regulatory Affairs Contractor

Job Description:

• Team is seeking a Regulatory Affairs Contractor to contribute to the development and execution of effective regulatory strategies for investigational products. The successful candidate will serve as a regulatory contact within an internal matrixed team environment.
• Execute integrated regulatory plans that deliver against strategic objectives, maintain compliance, and protect patients.
• Provide support to assigned clinical study and global regulatory teams.
• Assess regulatory program risks for likelihood and impact; help to establish mitigation strategies.
• Plan and prepare submissions to regulatory authorities, related to IND maintenance.
• Advise on regulatory requirements, expected outcomes, and changes to landscape.
• Strong information seeking skills and ability to work under moderate supervision.
• This person will interact with regulatory colleagues and matrixed project teams that may include clinical, medical, statistics, regulatory publishing and submissions, quality/CMC, medical writers, and other functions
• This position may require sitting/standing, focusing on computer screen for long periods of time and interacting with colleagues.

Qualifications :

• Bachelor's degree in a life sciences discipline
• 2+ years of relevant regulatory experience with drug or therapeutic biologic products required
• Oncology experience preferred
• General knowledge of the drug development process and US regulatory requirements, including expedited development programs for drugs to treat serious conditions
• Strong verbal and written communication skills.
• Strong organizational skills, ability manage conflicting priorities and adhere to tight timelines
• Proven ability to work with a high level of integrity, accuracy, and attention to detail

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.