What are the responsibilities and job description for the Regulatory Affairs Specialist / Pharma Industry / Hybrid Work (PT284) position at Pioneer Data Systems, Inc.?
Position Details:
Our client, a world-leading Pharmaceutical Company in Bothell, WA is currently looking for a Regulatory Affairs Specialist to join their expanding team.
Job Title: Regulatory Affairs Specialist / Pharma Industry / Hybrid Work
Duration: 12 months contract, extendable up to 36 months
Location: Bothell, WA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Regulatory Affairs Specialist
Summary:
The Client team is seeking a Regulatory Affairs Specialist 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.
Responsibilities:
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.
Qualifications:
Bachelor's degree in a life sciences discipline
A minimum of 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
Location/Schedule:
This is a hybrid role in Bothell, WA; hybrid schedule pending
Salary : $50 - $54
