Regulatory Affairs Manager
Galderma Laboratories

Dallas, Texas

Posted in Health and Safety


This job has expired.

Job Info


With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we're in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

Job Title: Regulatory Affairs Manager

Location: Dallas/Boston

Job Description

The Regulatory Affairs Manager is responsible for the oversight of promotional and labeling material development and review processes, including leading relevant promotional and scientific review committees, to ensure external materials are in compliance to applicable regulations and industry standards.

Key Responsibilities

  • Review advertising and promotional materials and other communications by Galderma to ensure its products are compliant to applicable FDA, FTC and state regulations.
  • Lead assigned promotional review committees, collaborating with colleagues from Medical Affairs, Legal and Commercial to drive innovative and compliant external advertising and other communications, while meeting business priorities.
  • Develop and manage product core claims documents to drive utilization for efficient promotional material development.
  • Works closely with other departments to develop medical and scientific communications, including external advisory board materials.
  • Review and approve labeling for assigned products in compliance with applicable FDA, FTC and state regulations.
  • Provide timely and accurate reports regarding changes in external environment that could impact promotional activities or products under development to appropriate level of management (e.g. changes in FDA Guidance, industry news, etc.).
  • Coordinate with team members to resolve any regulatory problems that impact promotional activities.
  • Represent the department on assigned cross-functional project teams.
  • Manage localized state reporting, licensing and drug reconciliation programs for the Prescription business unit.
  • Participates in the development of regulatory submissions (e.g. INDs, A/NDAs, sNDAs).
  • Coordinates with other team members to resolve any regulatory challenges and opportunities.
  • Compile, review and approve documentation for regulatory purposes.
  • Other duties as assigned.

Preferred Skills and Qualifications
  • A minimum of seven years of experience in the pharmaceutical or appropriately regulated industry is required. Minimum of three years working with pharmaceutical promotional materials is required.
  • Bachelor's degree in Pharmaceutical or related field is preferred but not required.
  • Have a thorough working knowledge of laws and regulations applicable Galderma's range of products in the United States is required.
  • Experience and/or working knowledge of labeling requirements and standards is required.
  • Ability to communicate and collaborate both internally and externally with colleagues, authorities, and affiliates is a must.
  • A high level of integrity and sense of urgency must be demonstrated.
  • Ability to manage time effectively, prioritize, and plan activities and projects well in advance taking account of possible changing circumstances.
  • Good writing and organizational skills.
  • Experience with electronic applications is preferred, but not required.
  • Experience with an electronic document management system is preferred, but not required.
  • Must be proficient with common business software (e.g. Microsoft Office) and similar systems.

What We Offer in Return

You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.

Next Steps
  • If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
  • The next step is a virtual conversation with the hiring manager
  • The final step is a panel conversation with the extended team

Our people make a difference

At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

Employer's Rights:

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not an employment contract, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.


This job has expired.

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