Manager, Regulatory Affairs Operations and Project Management

Job Description

The Manager of Regulatory Operations and Project Management will support the preparation and management of all activities related to regulatory submissions.  Primary responsibilities will include Word document processing/formatting, template management, PDF publishing and review, QC of published eCTD submissions, and archiving of submission and health authority correspondences.

The position will report to the Director, Regulatory Operations and Project Management.

Key Responsibilities:

• Assist in the preparation of regulatory submission documents in compliance with global regulatory requirements for different application types (eg, IND, NDA, MAA).
• Format complex Word documents to generate compliant regulatory reports including complicated tables and graphs created in a variety of formats. Maintain the internal regulatory styles template and manage submission templates.
• Format, edit, proof, and create bookmarks and hyperlinks according to guidance and internal processes.
• Ensure consistency across regulatory submission documents following the regulatory style guide.
• Provide technical expertise to cross-functional teams on format, style, and structure of compliant documents for electronic submissions.
• Provide input for scheduling and planning submission timelines.
• Coordinate with external publishing vendors and consultants for on-time delivery of high-quality regulatory submissions.
• Conduct final review of published submissions to ensure consistency and compliance with regulatory requirements.
• Execute regulatory information management tasks including file transfer, storing, tracking, and archiving regulatory submission documents/correspondence.
• Participate in the development of Regulatory Operations processes (SOPs, work instructions, guidelines, templates) for preparing submissions and regulatory information management.
• Maintain knowledge of global regulatory submission requirements.
• Other duties as assigned

Qualifications

• Bachelor’s degree and 5+ years of experience in Regulatory Operations with a working knowledge of electronic submissions.
• In depth, hands-on experience and expert level skills in Word processing, formatting, and PDF publishing for electronic submissions.
• Relevant experience with electronic document management and publishing systems (e.g., Veeva Vault RIM), and other publishing and QC tools (PDF Tools, TRS Toolbox), global regulatory submissions, or other experience directly related to Regulatory Operations.
• Proficiency with MS Word and Adobe Acrobat is a must.
• Committed to producing high quality and timely deliverables.
• Work independently and efficiently.
• Demonstrate flexibility, patience, and good verbal, written, and interpersonal communication skills.

Additional Information

Deciphera offers a comprehensive benefits package that includes but is not limited to the following:

• Non-accrual paid time off
• Summer vacation bonus
• Global, company-wide summer and winter shutdowns
• An annual lifestyle allowance
• Monthly cell phone stipend
• Internal rewards and recognition program
• Medical, Dental, and Vision Insurance
• 401(k) retirement plan with company match
• Life and Supplemental life insurance for family
• Short and Long Term Disability insurance
• Health savings account with company contribution
• Flexible spending account for either health care and/or dependent care.
• Family planning benefit
• Generous parental leave
• [if applicable] Car allowance

Deciphera, a member of ONO, is a company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a 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.  Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.