What are the responsibilities and job description for the Regulatory Affairs Specialist position at pfizer?
Regulatory Affairs Specialist
Summary:
The Pfizer 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
Please note contractors are engaged to provide services to Pfizer on a temporary basis in connection with a specific assignment. Contractors are hired and employed through Atrium, our third-party payrolling partner.
This job posting is for a temporary role as an employee of Atrium on assignment at Pfizer. The individual selected for this role will be offered the role as an employee of Atrium; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by Atrium upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements.
