The Drive to Discover. The Experience to Deliver.

Careers At Incyte Corporation

Looking for a challenge and a chance to grow your career?

Then Incyte is the pharmaceutical company for you. While our pipeline demonstrates the ability to compete with much larger pharmaceutical companies in selecting compelling targets and creating high-quality drug candidates, our smaller size enables employees to see the direct impact of their contributions on the direction of the company. Due to our smart, agile culture and cutting-edge science, we delivered a novel, first-to-market product in an unmet medical need in 2011 - the first in the company's history.

Opportunities for taking on new and/or additional responsibilities, in addition to advancement, are a key element in our culture. Add to that a science-based, fast-paced work environment and you’ve got an exciting company in which to work.

In addition to opportunities for growth, we offer an outstanding benefits andcompensation package to help meet personal needs as well.

Take a look at our current openings to find the match that’s right for you!

Incyte Corporation values the talents of our diverse workforce and is proud to be an Equal Opportunity Employer.

Sr Manager to Associate Director, Global Regulatory Affairs CMC

Department: Global Regulatory Affairs
Location: Incyte Corporate Headquarters

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. 

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary
The Senior Manager/Associate Director, Regulatory Affairs, CMC will primarily be responsible for managing regulatory CMC submissions and strategy for Incyte development and marketed products, including both small molecules and biologics, from early development through late-stage (phase 3, registration and post-approval).

Essential Functions of the Job (Key responsibilities/Basic job duties)

• Ensures global regulatory guidance documents and laws, as well as internal policies and procedures, are followed to ensure regulatory compliance is maintained.

• In alignment with RA-CMC leader, manages regulatory CMC strategy and submission aspects for both small and large molecule development programs to worldwide regulatory authorities. Large molecule experience is a plus.

• Provides critical review of the CMC data packages from other functional team representatives to support clinical trial and marketing applications world-wide.

• Ensures regulatory CMC submissions comply with current global regulatory standards, are of high quality, consistent and complete.

• Participates in and manages post-approval global product activities such as, but not limited to, change control, product complaints, marketing application supplements and variations.

• Works with CMC functional experts to provide timely responses to CMC regulatory questions from global health authorities.

• Participates in meetings with internal and external partners or teams for clinical development programs or collaborations, in order to communicate global regulatory CMC guidance and strategies.

• Liaises with FDA and other health authorities as needed (e.g. telephone contacts, submissions). Participates in regulatory CMC related health authority meetings for assigned projects. Prepares summaries of meetings and contacts for inclusion in the regulatory archives.

• Liaises with other regulatory and operations staff to ensure appropriate project support is provided.

• Maintains current knowledge of relevant US and international guidances, laws and regulations, and proposed and final rules which affect CMC pharmaceutical drug development.

• Participates in outside professional development meetings and conferences to ensure the latest thinking is applied to CMC strategies.

• Other responsibilities, as required.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• BA/BS degree is required. Advanced degree (M.S., Ph.D or Pharm.D.) in scientific, Regulatory Affairs, or related pharmaceutical field desirable.

• The Senior Manager requires a minimum of 3 years of experience and the Associate Director requires 4 to 8 years of experience in regulatory affairs CMC or a related pharmaceutical development field. Experience with regulatory CMC aspects of both large and small molecule drugs preferred. Experience with global clinical trial and/or marketing applications, eCTD submissions and electronic document management systems is required.

• In-depth knowledge of pharmaceutical drug development, and CMC regulations/ guidelines governing development of pharmaceuticals and/or biotechnology products is required.

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

We Respect Your Privacy

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The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job.   You can learn more about this process here.

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. 

You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).

Please contact if you have any questions or concerns or would like to exercise your rights.

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