Senior Manager, Regulatory Affairs
Apply NowCompany: Deciphera Pharmaceuticals, Inc.
Location: Waltham, MA 02453
Description:
Company Description
Position Summary:
The Senior Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development. In this role, the Senior Manager of Regulatory Affairs will support the regulatory lead on, or lead, program related projects and be responsible for interacting with multiple functions to manage high quality regulatory submissions.
This role is responsible for the supporting, or leading, regulatory submissions such as: investigational new drug applications (INDs), clinical trial applications (CTAs) and components of marketing applications as well as post-approval submissions and life-cycle maintenance activities.
Job Description
Key Responsibilities:
Qualifications
Additional Information
Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $137,000.00 - $189,000.00. 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:
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.
Position Summary:
The Senior Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development. In this role, the Senior Manager of Regulatory Affairs will support the regulatory lead on, or lead, program related projects and be responsible for interacting with multiple functions to manage high quality regulatory submissions.
This role is responsible for the supporting, or leading, regulatory submissions such as: investigational new drug applications (INDs), clinical trial applications (CTAs) and components of marketing applications as well as post-approval submissions and life-cycle maintenance activities.
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
- Bachelor's 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 drugs
- Excellent oral and written communication skills
- Ability to collaborate effectively with key stakeholders and coordinate and lead activities cross-functionally
Additional Information
Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $137,000.00 - $189,000.00. 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.