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Executive Director, Regulatory Affairs CMC and Device Regulatory

Remote

 

About Apogee Therapeutics
Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.
Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”
We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. 
If this sounds like you, keep reading!

 

Role Summary

We are seeking an Executive Director, Regulatory Affairs CMC and Device Regulatory to lead and oversee all CMC regulatory activities and execution for drug-device combination products, ensuring compliance with global regulatory requirements throughout the product lifecycle. This individual will work closely with cross-functional teams to guide the development, submission, and approval processes for combination products, while liaising with global regulatory authorities. The role requires a deep understanding of CMC regulatory requirements and the ability to navigate complex regulatory landscapes for biologics. 

Key Responsibilities 

  • Develop and implement comprehensive global CMC regulatory strategies for investigational drug-device combination products, ensuring alignment with product development and business goals.
  • Stay abreast of evolving global regulatory landscapes for combination products and proactively adapt strategies to maintain compliance and competitive advantage.
  • Lead the preparation and review of CMC regulatory submissions, including INDs, NDAs, BLAs, MAAs, CTAs, and amendments.
  • Oversee the preparation of high-quality CMC sections of regulatory submissions and ensure timely submissions.
  • Collaborate with R&D, Manufacturing, Quality, and Clinical teams to gather necessary data and ensure regulatory requirements are integrated into product development and manufacturing processes.
  • Provide strategic advice and guidance to senior management on CMC regulatory matters based on health authority feedback and global regulatory trends.
  • Identify and assess regulatory risks associated with combination products and develop mitigation strategies to address potential challenges.
  • Maintain a deep understanding of current and emerging global regulatory requirements for combination products and ensure the organization is prepared to meet these demands.

Ideal Candidate

Education: Advanced degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field. Ph.D. preferred.

Experience:

  • Minimum of 12-15 years of experience in Regulatory Affairs CMC within the pharmaceutical/biotechnology industry with significant experience in drug-device combination products.
  • Proven track record of successful CMC regulatory submissions and experience across multiple regions (e.g., US, EU, and Canada).

Knowledge and Skills:

  • In-depth understanding of the development processes for drug device combination products, including manufacturing, quality control, and clinical evaluation.
  • In-depth knowledge of global regulatory requirements.
  • Excellent/Strong communication skills with an ability to present to a variety of stakeholders and tailor message accordingly 
  • Strategic thinker with strong problem-solving abilities and attention to detail.
  • Ability to work effectively in a fast-paced, dynamic environment, managing multiple priorities and projects.
  • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless 
  • Ability to travel up to 10% travel

The anticipated salary range for candidates for this role will be $270,000-$300,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. 

 

What We Offer
  • A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
  • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and 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
  • Flexible PTO
  • Two, one-week company-wide shutdowns each year
  • Commitment to growing you professionally and providing access to resources to further your development
  • Apogee offers regular all team, in-person meetings to build relationships and problem solve
 
E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.
 
Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
 
To review our privacy policy, click here

 

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