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Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.


Specialist, Regulatory Affairs



This is what you will do:

  • 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.

You will be responsible for:

  • 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

You will need to have

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

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.


Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, parental status (including adoption or surrogacy), pregnancy (including childbirth, breastfeeding, or related medical conditions), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.


AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you’re interested in career opportunities with AstraZeneca, click here.

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Deadline: 05-05-2024

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