Senior Director, Regulatory Affairs, CMC

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.

The Role

The incumbent is responsible for hands on oversight and support of CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs (RA) activities for antibody directed cancer therapeutics.

This role will provide expert guidance and evaluation of CMC content from an RA perspective to support a range of regulatory submissions in the US and globally. Oversight and input will of necessity involve Module 3 content gap assessments, strategy and tactical approaches to presentation of information. Submission types include annual reporting through to marketing authorization applications in multiple regions. A very strong technical background with demonstrable writing and verbal communication skills is a must. Due to the type of content and complexity of information involved, an advanced scientific degree (i.e., MS or PhD) is highly preferred in conjunction with 10 years of progressively responsible RA and RA CMC support from a global perspective.

In The Role You Will

• Develop and provide strategy, vision and direction to multiple functions.
• Lead and support health authority CMC interactions, including BLA, audit and Manufacturing site activation and validation related activities.
• Implement companywide policies and practices.
• Provide input to executive management.
• Be accountable for function financial results which impact organization performance (within the context of RA CMC).
• Work consistently with abstract ideas or situations across functional areas of the business.
• Provide thorough assessments of intangible variables, identifies and evaluates fundamental issues, providing strategy and direction for multiple functional areas.
• Anticipate factors that could influence strategies and company position in the market.
• Establish and develop broader company strategy and translate that strategy into multi functional objectives.
• Identify potential strategic/tactical decisions that will affect the company's success for the next five years or longer.
• Interact with internal and external executive level management, requiring negotiation of extremely critical matters Influences policymaking and strategy based on communication strategies and persuasion skills.
• Partner with executive leadership team for the function to provide cohesive direction towards company goals.
• Be recognized as an influential leader.
• Develop and Oversee a team(s) to solve company-wide (including affiliated companies) matters RA CM
  
  

Qualifications: About You

• Advanced degree in a scientific discipline, preferably PhD or PharmD
• 12+ years of industry experience in pharmaceutical or biotech company
• 8+ years of experience working in regulatory affairs CMC including managing post-approval changes for commercial products
• Proficiency in regulatory (FDA, EMA, and ICH) guidelines
• Strong knowledge of current Good Manufacturing Practices (cGMP) and establishment registration requirements
• Experience in leading and writing CMC submissions is required
• Experience with post approval management of Quality by Design (QbD) filings, as well as experience with global filings highly desirable
• Sound understanding of CMC and QA-related issues
  
  

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.