Director, Regulatory Affairs

We are a dedicated group of scientists, physicians, and businesspeople working together toward one goal: to discover and develop therapies that can unleash the power of the body’s immune system to treat and potentially cure cancer. We are passionate about the work we do every day at Agenus to deliver on the promise of immuno-oncology. If you’re looking for an inspired environment, passionate colleagues, and a culture that nurtures learning, innovation and team success, we invite you to join us.

T He Role

The Agenus Regulatory team is seeking a motivated, resourceful, and collaborative team member to join the team. This candidate should be able to work cross-functionally, and complete assigned tasks independently with guidance from the Global Head, Regulatory to ensure Agenus adheres to global regulations.

The Director of Regulatory Affairs will develop and implement regulatory strategies for all assets in all stages including IND, NDA, and Lice Cycle Management activities across the Agenus portfolio. Reporting to the Global Head of Regulatory, the candidate must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential.

In The Role You Will

• Develop and implements regulatory strategies and contingencies for global product development (investigational, licensing/registration, and post-marketing support).
• Participate in team meetings to provide regulatory support and guidance.
• Provide guidance and expertise to senior management and other departments on all regulatory issues for the strategic development, planning, compilation and submission for all regulatory filings.
• Provide timely and effective communication updates on regulatory interactions to senior management and other internal stakeholders, as appropriate.
• Serve as the primary contact and liaise, negotiate and orchestrate with Health Authorities.
• Lead key health authority meetings, as needed, that could impact global product strategy.
• Edit or lead the editing of regulatory documentation based upon regulatory requirements and Company SOPs.
• Ensure compliance with existing regulatory applications (e.g. IND/CTA Maintenance).
• Assist with the preparation, writing and review of regulatory documents.
• Oversee late-stage development applications and marketing approved product applications.
• Work with partner company counterparts to support pharma partner requirements.
• Provide support on labeling and advertising matters.
• Interface with contractors, vendors and consultants.
• Maintain knowledge of regulatory environment, global regulations and guidance.
• Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
  
  

Qualifications: About You:

• BA/BS undergraduate degree in life sciences. MS, PhD or other relevant advanced degree preferred.
• 10 years of drug development experience inclusive of a minimum of 5 years in regulatory affairs with roles increasing in scope
• Strong knowledge of worldwide drug development and regulatory policy; demonstrated excellent judgement in Regulatory-focused drug development.
• Demonstrated ability to interpret and understand US regulations governing pharmaceutical industry.
• Comprehensive understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology.
• Strong written, verbal, and interpersonal communication skills, with the ability to effectively interact with individuals at all levels across organization.
• Prior experience with FDA and EMA submissions required.
• Ability to critically review regulatory scientific documents across non-clinical and clinical
• Ability to constructively challenge, question, and provide creative suggestions for regulatory trial processes in order to create the most efficient and effective methods to deliver quality clinical trial services.
• Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
• Strong leadership skills in leading team members and vendors.
• Strong organizational, communication and interpersonal skills
• Ability to prioritize, delegate and execute to meet project deadlines.
• At ease in start-up environment and effectiveness to deliver in low-structured environments.
  
  

Read more about our pipeline and visit us on LinkedIn

Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:

• Highly competitive and inclusive medical, dental and vision coverage options (US & UK)
• Flexible Spending Accounts for medical expenses and dependent care expenses (US)
• Flexible Vacation Plan (US & UK)-In a time when we move at the speed of light, what matters most is what we achieve, not how many hours we clock or accrue. We want people to take breaks when they need them most and own their time. Our philosophy at Agenus is that freedom to take this time will lead to clarity, creativity and innovation through rested and refreshed eyes. With our Flexible Vacation Plan, Agenus will not limit the amount of vacation you can take. It will allow you to take the vacation time as you need, while fulfilling your job responsibilities and making meaningful contributions to our mission.
• Care.com Memberships (US)
• Education Assistance Program (US & UK)
• 401k match (US) and Financial Planning tools, Private Pension (UK)
• Employee Stock Purchase Plans (US &UK)
• Employee Assistance Program (US &UK)
• Reward & Recognition Program (US & UK)
• Catered Lunch (site dependent)
• Onsite Yoga (UK)
• Free Parking (US & UK)
  
  

Our core values

The way we work sets Agenus apart.

We put the patient first.

We aspire to change the world, improving the experience and options available for every single cancer patient. The answers are out there, and patients are waiting.

We are bold, and we are one.

We believe that the only way to deliver on our goals is to aim high and work as one global team. We look for opportunities to challenge, collaborate with, and support one another. We aim to break conventional standards and perform at extraordinary levels.

We work with integrity, respect and honesty.

These three building blocks serve as pillars for how we behave, operate, and execute our mission.

We are a culture of ownership and accountability.

We hold ourselves accountable not only for exceptional results, but how we get our results.

We are obsessively curious and deeply committed to learning.

We live in a fast-paced environment that requires us to learn at or above the speed of change. We believe that curiosity fuels the desire to create, and learning provides the tools to progress.

We perform at our best every day.

Every day counts. We confront insurmountable obstacles, problems and choices with intellect, perseverance and hard work.