Senior Associate in Regulatory Affairs Strategy
2 weeks ago
OVERVIEW:
The individual in this role will be accountable for overseeing and sustaining current Investigational New Drug (IND), Clinical Trial Application (CTA), New Drug Application (NDA), and Biologics Licensing Application (BLA) submissions, while also preparing necessary amendments in accordance with established guidelines and regulations.
KEY RESPONSIBILITIES:
Examine clinical site regulatory documentation to ensure Regulatory approval for the shipment of investigational products.
Monitor safety reports and facilitate submissions to US INDs.
Support the Project Team Regulatory Representative in the preparation of routine IND, NDA, and BLA submissions, as well as ex-US CTAs, tracking the progress of submissions, and archiving regulatory documents and correspondence.
Act as a liaison with the FDA.Collaborate with consultants and contractors to achieve regulatory objectives and submissions.
SUPERVISORY ROLE:
No supervisory responsibilities
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
A Bachelor’s degree in a relevant field with a minimum of five years of pertinent experience; or,
A Master’s degree in a relevant field with a minimum of three years of pertinent experience; or,
A combination of education and experience deemed equivalent.
Experience/Ideal Candidate Profile:
Knowledge/Skills:
Ability to work autonomously and collaboratively to complete assigned tasks and achieve outcomes within set timelines. Demonstrates a commitment to delivering high-quality work.
Collects, maintains, and applies regulatory knowledge to fulfill assigned responsibilities.
Communicates effectively in both verbal and written forms, ensuring clarity and understanding. Keeps management informed in a timely manner.
Exhibits strong interpersonal skills and appreciates diverse perspectives.
Collaborates effectively with team members.
Employs an analytical mindset to address challenges relevant to the role.
Demonstrates self-leadership by managing and executing personal work responsibilities with integrity.
JOB COMPLEXITY:
Capable of adhering to established procedures for specific tasks.
Identifies task-related challenges and prioritizes activities accordingly.
Seeks assistance when encountering task-related challenges and implements suggested solutions.
WORKING ENVIRONMENT:
Willingness to travel approximately 10%
At Exelixis, we value a culture of growth and collaboration among enthusiastic, high-achieving individuals.
Our compensation structure reflects the labor market across various U.S. regions, with pay varying based on defined markets. The salary range for this position is $98,000 - $140,000 annually.
The offered salary may consider the candidate's geographic location, adjusting pay based on specific work settings.
The base salary will also reflect the candidate's job-related knowledge, skills, experience, and internal equity, among other factors.
In addition to the base salary, Exelixis provides a comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
Employees may also qualify for a discretionary annual bonus program, or if in field sales, a sales-based incentive plan.Exelixis offers employees the chance to purchase company stock, receive long-term incentives, enjoy 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the year.
DISCLAIMER:The preceding job description is intended to convey the general nature and level of work performed by employees in this classification.
It is not intended to be an exhaustive list of all duties, responsibilities, and qualifications required of employees assigned to this position.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment based on race, color, sex, age, national origin, religion, sexual orientation, gender identity, veteran status, disability, or any other federal, state, or local protected class.
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