Associate Director, Regulatory Affairs

Job Description

The Associate Director, Regulatory Affairs will join a group of highly motivated, top-notch regulatory professionals and will be a key player in shaping cohesive regulatory strategies across the product pipeline. This role provides regulatory support for oncology products in early-stage and late-stage development through post-approval. Additionally, the Associate Director is responsible for the oversight of clinical trial investigational new drug applications (INDs), clinical trial applications (CTAs), and marketing applications (BLAs and NDAs)

Responsibilities

• Develop regulatory strategies for oncology development programs
• Provide solid regulatory solutions and guidance to cross-functional teams and senior management
• Monitor global regulatory changes that may impact asset development
• Ensure compliance of regulatory strategies and submissions

Qualifications

• B.S/M.S. and 10+ years of work experience in pharmaceutical regulatory affairs
• 5+ years of regulatory experience working with global development and submission plans
• Advanced knowledge and experience in interpretation of regulations, guidelines, and precedents related to oncology drug development in the US and EU
• Experience filing INDs and/or NDAs and engagement with FDA and other regulatory bodies

Additional Information

Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $158,000.00 - $217,000.00. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.​

Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera’s competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable).

Benefits:

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
• Generous parental leave and family planning benefits.
• Outstanding culture and opportunities for personal and professional growth.

Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially.  We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.