Executive Director, Regulatory Operations

Syndax Pharmaceuticals is looking for an Executive Director, Regulatory Operations

At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

The Role:

The Executive Director, Regulatory Operations will be responsible for formulating and implementing a regulatory operations vision and strategy to achieve a best-in-class, fit for purpose regulatory operations organization for a commercial stage biotechnology company. The role will involve envisioning and implementing a fit for purpose RIM across R & D.  The role will be expected to proactively anticipate and mitigate regulatory operational risks and develop internal processes to ensure operational excellence and compliance with global regulatory requirements.  This role will be expected to build and lead a small team of regulatory operations professionals.

 Key Responsibilities: 

• Be a strategic thought partner to the Heads of Regulatory and IT on current and future direction of regulatory operations initiatives and strategies.
• Establish a Regulatory Project Management role to partner with Regulatory Strategists and CMC Regulatory to ensure flawless execution of regulatory strategy to meet corporate objectives.
• Develop and maintain a Regulatory Affairs Quality Management System including a system for providing training in partnership with Quality Assurance.
• Establish a fit for purpose electronic submission strategy and procedures.
• Build and maintain a communication strategy and platform for the Regulatory, Quality and Medical Writing organization.
• Accountable to concisely articulate regulatory operational risks and develop risk-mitigation strategies as well as evaluate opportunities to accelerate development in a fast-paced, dynamic environment.
• Accountable for actively maintaining a contemporary working knowledge of the global regulatory environment and identify and communicate the implications of regulatory trends that may impact the business.
• Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines.
• Prepare, plan and implement new processes and policies to improve efficiency of the Company.

 Desired Experience/Education and Personal Attributes: 

• Demonstrated deep understanding of Regulatory Information Management.
• Project management expertise with a demonstrated ability to lead complex outsourcing projects.
• Demonstrated ability to lead and inspire a diverse set of internal/external partners and stakeholders.
• Demonstrated cross functional and leadership in the regulatory operations field. 
• Outstanding communicator, able to effectively communicate ideas verbally and in written form.
• Forward thinker with the ability to recommend, influence and implement organizational change and continuous innovation.
• Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
• Ability to effectively lead and drive outcomes with diverse partners and suppliers.
• Bachelor’s degree: advanced degree preferred (MS, MBA, Ph.D.).
• 15+ years pharmaceutical industry experience with responsibility for major aspects of strategic planning, implementation, regulatory operations and project management.
• Experience building and leading a fit for purpose Regulatory Operation organization in the pharmaceutical or biotechnology industry.
• Demonstrated record of leading and driving business process transformation and organizational culture change
• Cross functional partnering skills, team-oriented and ability to drive outcomes are necessary skills in the environment.
• Experience working within corporate alliance partnerships is desirable.
• Must be solution oriented with demonstrated skills to innovate, analyze, solve problems, and foster a collaborative working environment.
• Ability to travel up to 10 %.

Location: Syndax has offices in Waltham, MA and New York City and has a dispersed workforce across the United States.

About Syndax:
Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include revumenib a highly selective menin inhibitor, and Niktimvo™ (axatilimab-csfr), a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment for both revumenib and Niktimvo. For more information, please visit www.syndax.com/ or follow the Company on X (formerly Twitter) and LinkedIn.

Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

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