Director, CMC Regulatory Affairs

Role Summary

As Director, CMC Regulatory Affairs, you will make key contributions to Regulatory Affairs activities within our organization. You will be responsible for planning and executing regulatory submissions that enable Spyre to supply its monoclonal antibodies (mAbs) and combination products to new and ongoing clinical trials. You will contribute to CMC development plans with the goal of ensuring Spyre performs the necessary studies to gain and maintain product approval(s) that are consistent with our target product profile(s). 

You will advise the team on CMC regulatory requirements and guidelines for monoclonal antibodies, particularly in parenteral dosage forms. You will help design drug-drug and/or biologic-biologic combinations products, including identifying the requirements for injection devices such as autoinjectors and pre-filled syringes. 

You will serve as a liaison with internal regulatory points of contact, the technical operations (CMC) team, and our contract development and manufacturing organizations (CDMOs), working closely with these stakeholders to submit our global clinical trial applications and investigational drug and device applications. 

Key Responsibilities

• Regulatory Strategy and Submissions:
  •  Develop and implement regulatory CMC strategies to agree with the internal team and regulators on the appropriate data and submissions to enable the supply of our monoclonal antibody products to the clinic. Develop bridging strategies as our early stage products progress to their final dosage form(s).
  • Prepare, review, and submit regulatory applications and dossiers to health authorities, such as the FDA, EMA, and other global regulatory agencies, ensuring timely and successful approvals.
  • Prepare effective written communications to regulatory agencies, responding to inquiries and requests in a professional and efficient manner.
• Leadership:
  • Build Spyre’s CMC regulatory affairs capability, ensuring that the company has sufficient processes, personnel, and consultants to meet our commitments to global health authorities.
  • Oversee contractors and guide team members to ensure that our CMC regulatory obligations are met. 
  • Provide regulatory guidance and support to cross-functional teams on CMC-related issues, including manufacturing, quality control, and supply chain. Inform the team of the latest global regulatory requirements and expectations.
  • Budget Management: Contribute to development and management of the regulatory affairs budget, ensuring cost-effective use of resources.
• Regulatory Interactions: Represent the company in interactions with regulatory agencies and participate in regulatory meetings, inspections, and audits as needed.
• Risk Management: Identify potential regulatory risks and proactively develop strategies to mitigate them. Monitor changes in regulatory landscapes and assess their impact on the company’s products.
• Regulatory Intelligence: Keep abreast of new and evolving regulations, guidelines, and best practices in the pharmaceutical industry and adapt company strategies accordingly.

 Ideal Candidate

• Bachelor's degree in a scientific discipline, preferably in Pharmacy, Chemistry, Biology, or related field. Advanced degree (MS, PhD) is a plus.
• A minimum of 8-10 years of experience in pharmaceutical regulatory affairs and/or related disciplines.
• Proven track record of successfully managing complex regulatory submissions.
• Proven experience managing the CMC aspects of clinical trial applications in the US and globally.
• Strong knowledge of global pharmaceutical regulations and guidelines, including FDA, EMA, and ICH requirements.
• In-depth knowledge of CMC regulatory requirements and guidelines for monoclonal antibodies, particularly in parenteral dosage forms. 
• Proficiency in technical writing, including the ability to author or contribute to documents such as IMPDs, Module 2.3 and Module 3 summaries, and technical CMC documents.
• Knowledge of bridging strategies that will be required to support CMC/device changes during course of development (formulation, route of administration, device) is a plus.
• Knowledge of drug-drug and biologic-biologic combination products, including coformulation strategies and regulatory considerations is a plus.
• Experience with injection devices such as autoinjectors, including familiarity with device regulations, requirements, and submission of IDE applications is a plus.
• Excellent leadership, communication, and interpersonal skills.
• Strong problem-solving and critical thinking abilities.
• Ability to meet deadlines and adapt to changing priorities.
• Proficiency in regulatory affairs software, document management systems, and word processing software.

What We Offer

• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture of our young company, wear multiple hats, and learn quickly.
• Market-competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Unlimited PTO
• Two, one-week company-wide shutdowns each year.
• Commitment to growing you professionally and providing access to resources to further your development.
• 100% remote team with frequent in-person meetings to build relationships and problem solve.

The expected salary range offer for this role is $215,000 to $233,000.  Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.