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Regulatory Contractor

lmjdnwstygivzwlr4davpil0fjeac503f5em529l58yp19ouif1l5b73opy9iwzs · 30+ days ago

Bothell, WA, US

$72k+
Estimation

Full-time

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Summary:
Seattle Genetics is seeking a Regulatory Affairs Associate 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.

Skills:

Verbal and written communication skills, multi-tasking, customer service skills and interpersonal skills.
Ability to work independently and manage ones time.
Ability to keep information organized and confidential.
Previous experience with computer applications, such as Microsoft Word, Excel and PowerPoint.

Education and Experience:

Bachelor's degree in a life sciences discipline.
2-4 years of relevant regulatory experience with drug or therapeutic biologic products required.
Oncology experience preferred.
Knowledge of US regulatory requirements and opportunities for expediting development programs for serious conditions.
Able to manage conflicting priorities and adhere to tight timelines.
Able to consider and account for multiple options and opinions.

Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on a number of factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).

Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee. •

Last updated on Nov 15, 2023

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