About Company
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. We are pioneers in science and our innovative medicines are used by millions of patients worldwide. Our mission is to push the boundaries of science to deliver life-changing medicines. At AstraZeneca, we believe in the power of collaboration and fostering an inclusive environment where everyone can thrive. Join us in making a meaningful difference to global health.
Job Description
We are seeking a highly motivated and detail-oriented Regulatory Affairs Associate to join our dynamic team in El Cid, West Palm Beach. This is an exciting opportunity to contribute to AstraZeneca’s mission of delivering life-changing medicines to patients worldwide. As a Regulatory Affairs Associate, you will play a crucial role in ensuring the timely preparation, submission, and maintenance of regulatory dossiers for our diverse portfolio of pharmaceutical products. You will work closely with cross-functional teams, including R&D, Clinical, and Manufacturing, to ensure compliance with global regulatory requirements and internal company standards. This role requires a strong understanding of regulatory guidelines, excellent communication skills, and a proactive approach to problem-solving. If you are passionate about regulatory science and eager to contribute to a company that puts patients first, we encourage you to apply. You will be instrumental in navigating the complex regulatory landscape, ensuring our innovative therapies reach those who need them most efficiently and effectively. We foster a culture of continuous learning and professional development, providing ample opportunities for growth within the organization.
Key Responsibilities
- Assist in the preparation, compilation, and submission of various regulatory documents, including INDs, NDAs, BLAs, MAAs, and amendments, ensuring accuracy and adherence to regional and global regulations.
- Maintain regulatory databases and tracking systems with current information, ensuring data integrity and accessibility.
- Support regulatory compliance activities by reviewing promotional materials, labeling, and manufacturing changes for adherence to approved submissions and regulatory guidelines.
- Liaise with internal stakeholders (e.g., Clinical, Non-Clinical, CMC, Medical Affairs) to gather necessary information and documentation for regulatory submissions.
- Monitor global regulatory intelligence and assess the impact of new regulations and guidance documents on AstraZeneca's product portfolio and development programs.
- Participate in the development and implementation of regulatory strategies for assigned projects, under the guidance of senior regulatory professionals.
- Manage and archive regulatory submissions and related correspondence in accordance with company procedures and regulatory requirements.
- Assist in preparing responses to health authority queries and requests for information.
- Contribute to the continuous improvement of regulatory processes and procedures.
Required Skills
- Bachelor's degree in a life science discipline (e.g., Pharmacy, Biology, Chemistry, or related field).
- Minimum of 36 months (3 years) of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Solid understanding of global regulatory guidelines and requirements (e.g., FDA, EMA, ICH).
- Excellent written and verbal communication skills, with the ability to convey complex information clearly and concisely.
- Strong attention to detail and meticulous organizational skills.
- Proficiency in using electronic document management systems and submission software.
- Ability to work effectively in a team-oriented, cross-functional environment.
- Demonstrated problem-solving capabilities and ability to manage multiple priorities simultaneously.
Preferred Qualifications
- Master's degree or Pharm.D. in a relevant scientific or regulatory field.
- Experience with specific therapeutic areas (e.g., Oncology, Cardiovascular, Respiratory).
- Familiarity with eCTD publishing software and processes.
- Previous experience interacting directly with health authorities.
- Certification in Regulatory Affairs (RAC).
Perks & Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance plans.
- Generous paid time off (vacation, sick leave, holidays).
- 401(k) retirement plan with company match.
- Life and disability insurance.
- Employee assistance program.
- Opportunities for professional development and continuing education.
- Supportive and collaborative work environment.
- Wellness programs and resources.
How to Apply
Interested candidates are encouraged to apply by clicking the application link below. Please ensure your resume and cover letter highlight your relevant experience and qualifications for this role. We look forward to reviewing your application and exploring how your expertise can contribute to AstraZeneca’s mission.