Regulatory Affairs Co-Op

Regulatory Affairs Waltham, Massachusetts


Description

Position Summary:

Apellis is offering a Co-Op (January 2020 - June 2020) opportunity for a motivated graduate student to join our team in January 2020. Apellis is a fast-paced, high-energy biotechnology company with offices in Waltham, Massachusetts, San Francisco, California, and Louisville, Kentucky. We are looking for smart, self-motivated people who want to make a large personal impact as part of a small company and are passionate about improving patients’ lives and well-being through complement immunotherapy.

Regulatory Affairs is one of the fastest growing fields in the biopharmaceutical industry and a career in regulatory affairs is a challenging and rewarding choice for those interested in science, medicine, pharmacy, project management, and related disciplines. This person will provide valuable support to a dynamic group while gaining insight into how drugs and medical devices are brought to market and promoted within the frameworks governed by the Food & Drug Administration (FDA), EMA and other regulatory authorities.

Responsibilities:

  • Support development of regulatory processes for new and changing company initiatives and healthy authority regulations
  • Track and document submissions and correspondences to and from Health Authorities
  • Support the preparation of submissions to regulatory authorities
  • Aid departmental efforts to rename and reorganize electronic regulatory files
  • Become familiar with FDA regulatory submission requirements, as well as other major markets, and participate in compilation of both clinical and technical regulatory submissions
  • Acquire knowledge regarding the interdependencies of various functions (ie. regulatory, clinical, manufacturing, legal, medical, US and global marketing) in preparation of NDA submissions
  • Participate in other projects as needed

Qualifications:

  • Background in Life Sciences or Pharmacy
  • Currently enrolled in a graduate program focused on Regulatory Affairs
  • Familiarity with drug development process is highly desirable
  • Knowledge of Regulatory Affairs, and/or Regulatory Operations
  • Familiarity with ICH, FDA, EMA and other major markets’ regulations
  • Strong skills in using MS office, especially Excel, Word, and PowerPoint. Knowledge of Visio, Adobe Acrobat, SharePoint, Smartsheet, and MS Project is a plus
  • Attention to details and analytical mindset along with strong written and oral communication skills

Physical Demands and Work Environment:

  • This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.
  • This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

 Company Background:

We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.

Visit http://apellis.com/about.html to learn more.

EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.