Job Detail

Specialist, Regulatory Affairs

Req ID: 16768
Job Category: Regulatory Affairs

Location: Zurich, Zurich

Posting Date: November 14, 2019

Attention: If you are a current Alexion employee, please apply via Alexion’s internal Life & Career portal. Note that you will need to be connected to the VPN if you are applying away from the office.

Alexion does not contact candidates via instant messaging or chat tools. At no time will we ask candidates for fees associated with obtaining software, nor do we provide employees with a cashier’s check to purchase new equipment. If you are contacted in this manner, please be aware that it is fraudulent, and please do not provide any information or money to these individuals. Applicants should only apply through this Alexion website. Any fraudulent activity should be reported to GSOC@alexion.com

Specialist, Regulatory Affairs

Location: Zürich, Switzerland

Position Summary

The Regulatory Affairs Specialist will

• Prepare regulatory submissions and contacts with regulatory agencies under the supervision of the regulatory lead


• Provide Regulatory input for applications submitted for Alexion products after discussion with regulatory lead if appropriate


• Support regulatory lead as regulatory representative in the respective teams charged with preparing submissions and communications with Health Authority regulations and company policies.


• Participate in the development of processes and procedures relevant to the submissions.


• Support for communications to responsible Regulatory Agency personnel in regards to submissions after discussion with regulatory lead if appropriate.

Principal Responsibilities

• Prepare regulatory submissions and contacts with regulatory agencies


• Participate in the development of processes and procedures relevant to the submissions


• Works collaboratively with the product team to ensure that quality and regulatory standards are considered throughout the product development life cycle.


• Share information on regulatory requirements.


• Continually monitor the regulatory environment to maintain expertise in regulatory principles, new issues, competitive products, and implications.


• Performs regulatory intelligence


• Supports the regulatory lead as regulatory representative within cross-functional teams to provide expert interpretation of relevant laws, regulations, and company policies.


• Propose improvement of the submissions process


• Ability to understand and interpret regulatory requirements and translate this into concrete propositions

Qualifications

Work experience

• 1+ year experience in  Regulatory  Affairs within the pharmaceutical industry is required


• Working  knowledge  of Agency regulations and industry standards pertaining to regulatory is essential


• Knowledge  of  the  drug  development  process  is  highly preferred


• Initial experience on regulatory submissions


• Good communication experience with regulatory agencies
   

Skills

• Understand context and content of regulatory submissions


• Good English oral and written communication skills are required


• Understanding of requirements for regulatory submissions


• Ability to support projects to completion/ experience working in project teams


• Ability to work in a flexible environment to meet all regulatory requirements and business requirements


• Good organizational skills


• Some travels required

Education

• Pharmacist  or  equivalent education in a life science (biology, chemistry, etc.); 

Zurich, Switzerland

Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World’s Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts’ Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.

Alexion’s aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.

As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.