Job Detail

Specialist, Regulatory Affairs

Req ID: 17473
Job Category: Regulatory Affairs

Location: Zurich, Zurich

Posting Date: January 9, 2020

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: Zurich, Switzerland (or Paris, France) – please indicate in the application which location is at your interest. 

Position Summary:

The Regulatory Affairs Specialist will

• Support regulatory submissions preparation 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.

Responsibilities: 

• Support the preparation of regulatory submissions and contacts with regulatory agencies


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


• Work 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.


• Collate, analyse and communicate 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

Qualifications: 

Work experience

• 2 years’ experience in  Regulatory  Affairs within the pharmaceutical industry is required; biotech is a plus


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


• Initial experience on regulatory submissions


• Good communication experience with regulatory agencies


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

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 two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) as well as the first and only approved complement inhibitor to treat atypical hemolytic uremic syndrome (aHUS), anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). 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 several mid-to-late-stage therapies, including a second complement inhibitor, a copper-binding agent for Wilson disease and an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases as well as several early-stage therapies, including one for light chain (AL) amyloidosis and a second anti-FcRn therapy. 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. Further information about Alexion can be found at: www.alexion.com.