Senior Manager Regulatory Affairs
Senior Manager Regulatory Affairs
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Key Responsibilities:
- Provide input to global regulatory submission strategy preparing regulatory submission documents and reviewing regulatory submissions for completeness and quality in global accordance with regulatory agency requirements standards and corporate practices
- Previous experience with compilation and filing of INDs IND amendments NDA NDA supplements and CTAs.
- Represent the regulatory affairs function on project teams to provide regulatory support and advice
- Interact with or lead corporate partners and contracted vendors regarding various regulatory matters
- Provide support for regulatory interactions including meetings and teleconferences with global health authorities
- Show good judgment to determine when to escalate problems to his/her superior
- Draft and/or modify applicable SOPs and/or other written practices relating to the regulatory affairs function
Qualifications :
- Bachelors degree preferably in a scientific discipline
- 8 years experience in the pharmaceutical industry
- 4 years experience in regulatory affairs
- Strong working knowledge of U.S. and international regulatory requirements for oncology
- Excellent oral and written communication skills
- Ability to collaborate effectively with key stakeholders and coordinate and lead activities crossfunctionally
Additional Information :
Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $137000.00 $189000.00. 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 Decipheras competitive total rewards strategy that also includes annual performance bonus a longterm 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 nondiscriminatory basis.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
