Regulatory Affairs Specialist

About the Team

LexisNexis Reed Tech serve manufacturers and distributors of medical devices and drug products, and those who support them in consulting and IT roles by delivering better outcomes for the collection, transformation, submission, and analysis of regulatory data. Our solutions support the innovation ecosystem and enable you to achieve regulatory compliance and improved product data management contributing to impactful innovations to our world.

About the Role

We are seeking a versatile and strategic Regulatory Affairs Specialist to join our dynamic Reed Tech Life Sciences Professional Services. The ideal candidate will be a regulatory affairs generalist with a strong foundation in labeling and regulatory submissions. This role requires a unique blend of client acumen, business acumen, and financial acumen, as well as the ability to think strategically while executing operational tasks.

Requirements

• Bachelor's degree in life sciences, pharmacy, or a related field. Advanced degree preferred.
• Experience in regulatory affairs, with a focus on labeling and regulatory submissions.
• Strong knowledge of FDA regulations, guidelines, and submission processes.
• Excellent project management skills, with the ability to manage multiple projects simultaneously.
• Strong client-facing skills, with the ability to build and maintain positive relationships.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Strategic thinker with the ability to analyze complex regulatory situations and provide innovative solutions.
• Detail-oriented with a commitment to quality and accuracy.
• Proficient in Microsoft Office Suite and regulatory submission software.

Responsibilities

Regulatory Submissions:

• Support regulatory submissions, including 510K, INDs, NDAs, ANDAs, and DMFs.
• Ensure compliance with Health Authority's regulations and guidance for regulatory submissions.
• Collaborate with cross-functional teams to gather necessary data and documents for submissions.
• Monitor and manage the progress of regulatory submissions and provide timely updates to clients and internal stakeholders.

Labeling:

• Review and develop product labeling, including package inserts, carton labels, and instructions for use.
• Ensure labeling content complies with FDA regulations and guidelines.
• Collaborate with marketing, medical affairs, and legal teams to ensure accurate and compliant labeling.
• Manage the labeling review and approval process, including interactions with regulatory agencies.
• Develop and maintain Structured Product Labeling (SPL) documents in accordance with FDA requirements.

Regulatory Strategy:

• Contribute to the development of regulatory strategies for clients' products and programs.
• Support strategic guidance on regulatory pathways, requirements, and timelines.
• Assess regulatory risks and opportunities and recommend appropriate actions.
• Stay up-to-date with regulatory trends, changes, and best practices to inform strategic decision-making.

Client and Business Acumen:

• Develop and maintain strong relationships with clients, understanding their unique needs and objectives.
• Communicate effectively with clients, providing expert guidance and support throughout the regulatory process.
• Identify and pursue opportunities to expand client engagements and generate new business.
• Contribute to the development of proposals, budgets, and timelines for regulatory consulting projects.

Financial Acumen:

• Demonstrate understanding of financial concepts and their impact on regulatory consulting services.
• Identify opportunities for cost savings and process improvements to enhance profitability.
• Collaborate with finance and accounting teams to ensure accurate billing and financial reporting.

Work in a way that works for you

We promote a healthy work/life balance across the organization, with various flexible and remote working options available to employees.

Working with Us

LexisNexis Legal & Professional is proud to be an equal-opportunity employer. We are committed to equal opportunity employment regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. Together, we are building a diverse and inclusive workplace.

Working for you

We believe in a healthy work/life balance. We know that your well-being and happiness are key to a long and successful career. These are some of the benefits we are delighted to offer:
- Comprehensive, multi-carrier health plan benefits
- Disability insurance
- Dependent care and commuter spending accounts
- Life and accident insurance
- Retirement benefits (salary investment plan/employer stock purchase plan)
- Modern family benefits, including adoption and surrogacy

About our Team

LexisNexis is a data and analytics company with 10,500 colleagues serving customers in more than 150 countries. We’re one of the largest information and analytics companies on the planet. We design solutions that help our customers increase productivity, improve decision-making and outcomes, and be more successful.

LexisNexis, a division of RELX Group, is an equal opportunity employer: qualified applicants are considered for and treated during employment without regard to race, color, creed, religion, sex, national origin, citizenship status, disability status, protected veteran status, age, marital status, sexual orientation, gender identity, genetic information, or any other characteristic protected by law. We are committed to providing a fair and accessible hiring process. If you have a disability or other need that requires accommodation or adjustment, please let us know by completing our Applicant Request Support Form: , or please contact 1-855-833-5120.

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