Regulatory Affairs Pharmacist

We are seeking a highly skilled and detail-oriented Regulatory Affairs Pharmacist to join our team. As a Regulatory Affairs Pharmacist, you will be responsible for ensuring compliance with all relevant regulations and guidelines relating to pharmaceutical products. This includes overseeing the submission and approval process for new drugs, managing the documentation and labeling requirements, and providing guidance on regulatory issues to all relevant departments within the company.

Responsibilities

• Oversee the preparation and submission of regulatory documents to health authorities, ensuring they are accurate, complete, and in compliance with all applicable regulations and guidelines
• Develop and maintain relationships with regulatory agencies to facilitate efficient and timely approvals
• Stay up-to-date with changes in regulations and guidelines, and assess their impact on our products and processes
• Collaborate with cross-functional teams, such as Research and Development, Quality Assurance, and Manufacturing, to ensure regulatory compliance throughout the product lifecycle
• Participate in internal and external audits, and address any findings or recommendations related to regulatory affairs
• Review and approve product labeling, packaging, and promotional materials to ensure compliance with regulations
• Provide guidance and training to employees on regulatory requirements and processes

Requirements

• Bachelor's degree in Pharmacy or a related field, with a valid Pharmacist license
• Minimum of 3 years of experience in regulatory affairs within the pharmaceutical industry
• Strong knowledge of FDA regulations and guidelines
• Experience in preparing and submitting regulatory documents, such as INDs, NDAs, and BLAs
• Excellent attention to detail and organizational skills
• Strong analytical and problem-solving abilities
• Effective communication and interpersonal skills, with the ability to collaborate with cross-functional teams
• Ability to work independently and manage multiple projects simultaneously
• Proficiency in Microsoft Office Suite and regulatory affairs software applications
• Understanding of international regulations and guidelines is a plus

About WALGREENS

Founded over a century ago in 1901, we have a rich and colorful history of continuous improvement and innovation at Walgreens. From inventing the world's first chocolate malted milkshake to the creation of one of the most popular and sophisticated mobile applications in retail shopping today, we have transformed ourselves into a leader within the retail and drug industry. Walgreens, one of the nation's largest drugstore chains, is the Retail Pharmacy USA Division of Walgreens Boots Alliance, Inc., a global leader in retail and wholesale pharmacy.

In the U.S., Walgreens is the neighborhood retailer that makes health and well-being within reach for everyone on a daily basis. We are 240,000 team members strong and one of the largest drugstore chains in the U.S., with nearly 9,000 stores in all 50 states, the District of Columbia, Puerto Rico and the U.S. Virgin Islands. In fact, did you know there's a Walgreens store located within five miles of approximately 78 percent of all Americans? And every day, we touch the lives of more than 8 million customers in our stores and online.

We're also a trusted wellness provider that supplies customers, patients and payers with everything from acute prescriptions and vaccinations to specialty pharmaceuticals and wellness services. And to our team members, Walgreens represents a unique opportunity to excel in their careers in a welcoming and inclusive environment.