Associate Director, Regulatory Affairs
Share
Job Location:
Waltham, MA - USA
Monthly Salary:
Not Disclosed
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
We are seeking a dynamic and strategic Associate Director Regulatory Affairs to join our Regulatory Affairs team. The Associate Director of Regulatory Affairs leads the development and execution of global regulatory strategies to support the approval and lifecycle management of pharmaceutical products. This role partners cross-functionally with R&D Clinical Quality and Commercial teams to ensure regulatory alignment with business objectives and compliance with global health authority requirements. The Associate Director provides expert guidance on regulatory pathways risk assessment and submission strategies.
Key Responsibilities
Regulatory Strategy (50%)
- Develop regulatory strategies for clinical development programs (which may range from FIH through post-marketing stage.
- Provide solid regulatory solutions and guidance to the cross-functional teams and senior management.
- Provide tactical support and operational expertise with hands on support as needed.
Project Management (25%)
- Assess project plans and timelines.
- Work collaboratively to ensure all projects are appropriately prioritized and key goals are met on time.
Regulatory Compliance (25%)
- Ensure compliance of regulatory strategies and submissions.
- Oversee preparation and review of regulatory submissions and responses.
- Monitor regulatory trends and ensure proactive strategy adjustments.
- Other duties and responsibilities as assigned.
Qualifications :
Required 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
- Must have experience filing INDs and NDAs and engagement with FDA and other regulatory bodies
Preferred Experience
- Capable of strategic thinking and proposing innovative solutions to regulatory problems
- Demonstrates excellent verbal and written communication skills
- Experience managing a regulatory team member
Additional Information :
Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $162200 - $223000. 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 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.
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.
Remote Work :
Yes
Employment Type :
Full-time
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
