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.
This is what you will do: This position is responsible for developing and managing innovative product registrations and regulatory life-cycle-management for Alexion portfolio products. The Associate Director (AD), Regulatory Affairs will ensure full compliance with all Canada regulations and corporate policies and act as the main contact with the local Health Authority
You will be responsible for:

• Responsible for all interactions with local Health Authority including Health Authority meetings
• Submissions and management for new product registrations and indication extensions
• Develop and execute effective regulatory strategies for product registration (and life cycle management)
• Responsible for regulatory compliance to local Marketing Authorizations
• Oversee the Drug Establishment License (DEL) updates and renewal to ensure compliance to local Health Authority GMP requirements
• Lead local regulatory team to deliver on local responsibilities and deliverables as aligned with business priorities
• Coach and mentor direct reports enabling active learning, stretch goals, risk-taking, innovative thinking and development plan
• Ensures RQA Director and Canadian Leadership Team (CLT) are informed of regulatory risks, advice on course of action and/or escalate when appropriate
• Collaborate closely and provide support to local Quality team to ensure QMS compliance to Local Health Authority GMP requirements
• Responsible for local review of risk management plan
• Review and approval of local labeling (including translations), including development of local labels based on CCDS
• Negotiates and manages local post-approval commitments
• Submission and management of procedure for Clinical Trial application (CTA) /Notifications (CTN) plans
• In collaboration with global regulatory leads (GRL), influence the global development of a portfolio of products, representing the Canadian regulatory environment and market, to mitigate regulatory risks in the development plans
• Collaboration with cross-functional team (e.g., Commercial, Medical, Access, etc.) to define regulatory priorities based on business opportunities
• Provides local regulatory/competitior environment intelligence and advice anticipating regulatory hurdles and business risks
• Oversees all promotional items (including training material) and local press releases
• Provide input on emerging Canadian regulations/policies/guidelines/initiatives/surveys
• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to the role
• Identify and implement process improvement initiatives

You will need to have:

• Bachelor\xe2\x80\x99s degree, preferably in life sciences
• Minimum 7 years work experience in regulatory affairs in the country
• Strong knowledge of local regulatory environment and excellent understanding of all stages of drug development including pre and post approval stages
• Proven track record of effective collaboration with Health Canada in gaining approvals and maintenance of approved products
• Knowledge of EMA and FDA regulations
• Ability to build team relationship and collaborate in a local and global team environment at all level of the organization
• Strong interpersonal; communication and leadership skills

We would prefer for you to have:

• Advanced degree (PharmD or PhD) preferred but not required
• Experience in biologics is preferred

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, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), 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.