Alexion Pharmaceuticals, Inc.
Associate Regulatory Affairs Director
Alexion Pharmaceuticals, Inc., Boston, Massachusetts, us, 02298
Join to apply for the
Associate Regulatory Affairs Director
role at
Alexion Pharmaceuticals, Inc. 3 days ago Be among the first 25 applicants Join to apply for the
Associate Regulatory Affairs Director
role at
Alexion Pharmaceuticals, Inc. The Associate Regulatory Affairs Director (RAD), Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for assigned project(s)/product(s) and regulatory jurisdiction(s), with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.
Scroll down to find the complete details of the job offer, including experience required and associated duties and tasks.
This individual will provide tactical and strategic input to and leadership across regulatory and cross-functional teams with the objective of delivering according to regional and global Business Objectives. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.
You Will Be Responsible For
Accountable for the regulatory execution of submissions in the relevant regulatory jurisdiction(s), by actively collaborating with other Regulatory functions and cross-functional teams (e.g. clinical trial applications, marketing authorization applications, orphan drug designation applications, paediatric submissions, etc.). Actively be up to date on latest regulatory requirements and trends, and contribute to the shaping of the regulatory science environment. Support regulatory intelligence and policy priorities based on Alexion and AstraZeneca’s internal knowledge and expertise. Supports relevant internal activities, including development and management of select Regulatory processes and procedures, as well as inspection/audit support. Demonstrate strategic leadership skills contributing to effective product development. Provide team leadership and participate in mentoring, and performance feedback to regulatory and cross-functional colleagues. Ensure exemplary behavior, leadership, ethics and transparency within the Enteprise, with Health Authorities and other external stakeholders.
Qualifications
Bachelor’s Degree, life science Postgraduate degrees relevant to the role (e.g. MSc, PhD, PharmD, MD) a plus 7+ years of relevant Regulatory experience in the pharmaceutical industry, with experience in regional regulatory strategies (e.g. EU, US, UK, Canada). Strong knowledge of drug development and regulatory environment, coupled by excellent scientific and business judgment. Experience providing strategic regulatory advice in at least one several regulatory jurisdiction(s) (e.g. EU, US, Canada, UK) for the global development of products through most stages of development including pre-approval and marketed assets. Ability to manage complex issues and lead multiple projects simultaneously in a time-sensitive fashion. Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization, especially Senior Management. Strong interpersonal, written/verbal communication and presentation skills. Proven track record practicing sound judgment as it relates to risk assessment Highly conversant and knowledgeable of new and emerging regulations and guidances. Understanding of GxPs at relevant areas and solid understanding of where to seek and how to interpret regulatory information. Excellent use of Microsoft 365 (Office) tools, ideally well skilled on the use of PowerPoint Experience working in regulatory documentation system (like Veeva) Proficient in English in the Corporate setting. Additional languages are a plus Additional certification and/or training relevant to the role
When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines! In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca's Alexion division, we push boundaries in rare disease biopharma by translating complex biology into transformative medicines. Our commitment to transparency, objectivity, and ethics drives us to meet unmet medical needs. With our global reach and resources, we are shaping the future of rare disease treatment, helping people live their best lives. Ready to make a difference? Apply now!
Date Posted
06-Aug-2025
Closing Date
20-Aug-2025
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionLegal Referrals increase your chances of interviewing at Alexion Pharmaceuticals, Inc. by 2x Sign in to set job alerts for “Associate Director Regulatory Affairs” roles.Associate Director/Director, Regulatory AffairsAssociate Director, Global Regulatory Affairs Boston, MA $153,600.00-$241,340.00 1 month ago Associate Director, Global Regulatory AffairsAssociate Director, Regulatory Affairs Strategy Cambridge, MA $149,069.00-$223,604.00 1 month ago Boston, MA $200,000.00-$230,000.00 2 weeks ago Associate Director, Global Regulatory Affairs - GI & Inflammation Boston, MA $153,600.00-$241,340.00 1 month ago Senior Regulatory Affairs Specialist (IVD Exp. supporting US/Health Canada) Boston, MA $87,892.99-$118,774.78 5 days ago Marlborough, MA $113,700.00-$189,400.00 1 week ago Boston, MA $172,521.00-$202,540.00 1 month ago Associate Director, Global Regulatory Affairs, CMC Small Molecules Boston, MA $153,600.00-$241,340.00 1 month ago Associate Director, Global Regulatory Affairs - GI & Inflammation Boston, MA $153,600.00-$241,340.00 3 days ago Associate Director, Global Regulatory Affairs, Advertising and PromotionAssociate Director, Global Regulatory Affairs – Global Labeling Strategy Cambridge, MA $147,000.00-$212,333.33 2 days ago Associate Director, Global Regulatory Affairs, CMC Small MoleculesSenior Manager, Regulatory Affairs CMC (Hybrid Onsite) Waltham, MA $121,000.00-$230,000.00 2 weeks ago Greater Boston $172,521.00-$249,862.00 2 weeks ago Associate Director, Regulatory Affairs, Advertising and PromotionSr. Regulatory Affairs Specialist (Austin, TX)Senior Regulatory Affairs Licensing Engineer (remote eligible) Boston, MA $111,000.00-$162,000.00 2 weeks ago Associate Director, Global Regulatory Affairs - GI & Inflammation Boston, MA $153,600.00-$241,340.00 3 weeks ago Manager, External and Regulatory AffairsAssociate Director, Global Regulatory Affairs Boston, MA $153,600.00-$241,340.00 2 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Associate Regulatory Affairs Director
role at
Alexion Pharmaceuticals, Inc. 3 days ago Be among the first 25 applicants Join to apply for the
Associate Regulatory Affairs Director
role at
Alexion Pharmaceuticals, Inc. The Associate Regulatory Affairs Director (RAD), Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for assigned project(s)/product(s) and regulatory jurisdiction(s), with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.
Scroll down to find the complete details of the job offer, including experience required and associated duties and tasks.
This individual will provide tactical and strategic input to and leadership across regulatory and cross-functional teams with the objective of delivering according to regional and global Business Objectives. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.
You Will Be Responsible For
Accountable for the regulatory execution of submissions in the relevant regulatory jurisdiction(s), by actively collaborating with other Regulatory functions and cross-functional teams (e.g. clinical trial applications, marketing authorization applications, orphan drug designation applications, paediatric submissions, etc.). Actively be up to date on latest regulatory requirements and trends, and contribute to the shaping of the regulatory science environment. Support regulatory intelligence and policy priorities based on Alexion and AstraZeneca’s internal knowledge and expertise. Supports relevant internal activities, including development and management of select Regulatory processes and procedures, as well as inspection/audit support. Demonstrate strategic leadership skills contributing to effective product development. Provide team leadership and participate in mentoring, and performance feedback to regulatory and cross-functional colleagues. Ensure exemplary behavior, leadership, ethics and transparency within the Enteprise, with Health Authorities and other external stakeholders.
Qualifications
Bachelor’s Degree, life science Postgraduate degrees relevant to the role (e.g. MSc, PhD, PharmD, MD) a plus 7+ years of relevant Regulatory experience in the pharmaceutical industry, with experience in regional regulatory strategies (e.g. EU, US, UK, Canada). Strong knowledge of drug development and regulatory environment, coupled by excellent scientific and business judgment. Experience providing strategic regulatory advice in at least one several regulatory jurisdiction(s) (e.g. EU, US, Canada, UK) for the global development of products through most stages of development including pre-approval and marketed assets. Ability to manage complex issues and lead multiple projects simultaneously in a time-sensitive fashion. Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization, especially Senior Management. Strong interpersonal, written/verbal communication and presentation skills. Proven track record practicing sound judgment as it relates to risk assessment Highly conversant and knowledgeable of new and emerging regulations and guidances. Understanding of GxPs at relevant areas and solid understanding of where to seek and how to interpret regulatory information. Excellent use of Microsoft 365 (Office) tools, ideally well skilled on the use of PowerPoint Experience working in regulatory documentation system (like Veeva) Proficient in English in the Corporate setting. Additional languages are a plus Additional certification and/or training relevant to the role
When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines! In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca's Alexion division, we push boundaries in rare disease biopharma by translating complex biology into transformative medicines. Our commitment to transparency, objectivity, and ethics drives us to meet unmet medical needs. With our global reach and resources, we are shaping the future of rare disease treatment, helping people live their best lives. Ready to make a difference? Apply now!
Date Posted
06-Aug-2025
Closing Date
20-Aug-2025
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionLegal Referrals increase your chances of interviewing at Alexion Pharmaceuticals, Inc. by 2x Sign in to set job alerts for “Associate Director Regulatory Affairs” roles.Associate Director/Director, Regulatory AffairsAssociate Director, Global Regulatory Affairs Boston, MA $153,600.00-$241,340.00 1 month ago Associate Director, Global Regulatory AffairsAssociate Director, Regulatory Affairs Strategy Cambridge, MA $149,069.00-$223,604.00 1 month ago Boston, MA $200,000.00-$230,000.00 2 weeks ago Associate Director, Global Regulatory Affairs - GI & Inflammation Boston, MA $153,600.00-$241,340.00 1 month ago Senior Regulatory Affairs Specialist (IVD Exp. supporting US/Health Canada) Boston, MA $87,892.99-$118,774.78 5 days ago Marlborough, MA $113,700.00-$189,400.00 1 week ago Boston, MA $172,521.00-$202,540.00 1 month ago Associate Director, Global Regulatory Affairs, CMC Small Molecules Boston, MA $153,600.00-$241,340.00 1 month ago Associate Director, Global Regulatory Affairs - GI & Inflammation Boston, MA $153,600.00-$241,340.00 3 days ago Associate Director, Global Regulatory Affairs, Advertising and PromotionAssociate Director, Global Regulatory Affairs – Global Labeling Strategy Cambridge, MA $147,000.00-$212,333.33 2 days ago Associate Director, Global Regulatory Affairs, CMC Small MoleculesSenior Manager, Regulatory Affairs CMC (Hybrid Onsite) Waltham, MA $121,000.00-$230,000.00 2 weeks ago Greater Boston $172,521.00-$249,862.00 2 weeks ago Associate Director, Regulatory Affairs, Advertising and PromotionSr. Regulatory Affairs Specialist (Austin, TX)Senior Regulatory Affairs Licensing Engineer (remote eligible) Boston, MA $111,000.00-$162,000.00 2 weeks ago Associate Director, Global Regulatory Affairs - GI & Inflammation Boston, MA $153,600.00-$241,340.00 3 weeks ago Manager, External and Regulatory AffairsAssociate Director, Global Regulatory Affairs Boston, MA $153,600.00-$241,340.00 2 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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