Associate Director, Global R&D Compliance Lead

Galderma

Boston (MA)

On-site

USD 160,000 - 210,000

Full time

8 days ago
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Benefits offered by this job

Medical, dental, vision
401(k) match
Paid time off

Job summary

Galderma in Boston seeks an Associate Director, Global R&D Compliance Lead to oversee the R&D compliance program and serve as primary contact for GFRC and related activities.

You will collaborate with Global Medical Affairs, KOL management, and cross-functional teams to ensure adherence to regulatory requirements and internal policies. The role requires deep knowledge of US and international pharmaceutical compliance and a track record in leading compliance initiatives.

Qualifications

  • Bachelor's degree required; lawyer qualification strongly preferred.
  • 7+ years advising pharma/biotech/medical device on compliance matters.
  • Experience with U.S. and international healthcare compliance for prescription products and devices.
  • Deep knowledge of pharmaceutical industry regulations and enforcement guidance.

Responsibilities

  • Serves as the primary compliance point of contact for the R&D organization (including Global Medical Affairs).
  • Oversees the compliance program for R&D, aligning with regulator expectations and codes of practice.
  • Serves on the Global Funding Review Committee (GFRC) as primary compliance contact.
  • Manages research and consultancy arrangements with KOLs, ensuring oversight of spend.
  • Ensures compensation and remuneration are captured and routed to transparency processes.
  • Manages FMV processes and rates.
  • Supports governance for Investigator Initiated Studies, clinical trials and funding requests.
  • Leads training of global R&D personnel on compliance policies.
  • Leads risk and monitoring activities and remediation.
  • Monitors regulatory environment to assess impact on compliance programs.

Skills

Healthcare compliance
R&D compliance
Regulatory strategy
Leadership
Policy development
Cross-functional collaboration

Education

Bachelor's Degree
Law qualification (preferred)

Job description

Job Title

Associate Director, Global R&D Compliance Lead

Job Location

Boston, MA

The Opportunity

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare 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 are 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.

Key Responsibilities
  • Serves as the primary compliance point of contact for the R&D organization (including Global Medical Affairs).
  • Oversees Galderma’s compliance program relevant to R&D matters, ensuring alignment with regulator expectations and Galderma’s own compliance program, relevant codes of practice and relevant country laws and regulations.
  • Serves on, and as the primary compliance contact for, the Global Funding Review Committee (GFRC).
  • Manages Galderma’s research and consultancy arrangements, in particular with those healthcare practitioners (HCPs) serving as Key Opinion Leaders (KOLs) ensuring visibility and oversight of Galderma's global and in-market spend for such KOLs.
  • Ensures compensation and other remuneration provided to HCPs, HCOs, and other covered persons/entities under arrangements are appropriately captured and routed to Galderma’s financial transparency processes and systems.
  • Manages and serves as the primary interface for Galderma’s FMV processes and specific rates.
  • Supports and advises on internal governance related to the review and approval of Investigator Initiated Studies (IIS), clinical trial activities and research funding requests.
  • Leads and co-ordinates the training of global R&D personnel on R&D-specific compliance policies and procedures.
  • Leads and co-ordinates R&D risk & monitoring activities, and related remediation.
  • Supports and advises on internal governance related to the review and approval of congress and meeting activities.
  • Monitors the regulatory and broader compliance environment to determine the potential impact of regulatory changes on compliance programs as they affect R&D and drive necessary changes to relevant compliance policies and processes.
Qualifications
  • Bachelor's Degree required; lawyer qualification strongly preferred.
  • 7+ years of experience advising a pharmaceutical, biotechnology or medical device company on compliance matters required, with 3 years of in‑house experience preferred.
  • Strong understanding of healthcare compliance and broader legal and regulatory framework laws, including regulations and guidance applicable to the pharmaceutical and medical device industries.
  • Significant experience advising R&D organization(s) on R&D and related matters.
  • Expertise and significant experience advising on U.S. and international healthcare compliance for prescription products and devices, including specifically in respect of R&D activities.
  • Deep knowledge of pharmaceutical industry regulations and therapeutic areas, and of the laws, regulations, and industry guidance relevant to the commercialization of pharmaceutical products (including but not limited to the U.S. Federal Anti‑Kickback Statute, False Claims Act, Food Drug and Cosmetic Act, OIG and DOJ Guidelines, PhRMA Code, and U.S. state and local marketing compliance laws and relevant government enforcement actions).
  • Experience developing, designing, and implementing compliance training programs, developing risk management strategies, and drafting policies and standard operating procedures.
Interpersonal Competencies & Success Factors
  • Proven track record of developing, building, and implementing effective compliance programs.
  • Strong and proven strategic leadership skills, with executive presence and gravitas.
  • Ability to identify and drive improvement and new initiatives throughout the organization.
  • Energetic leader with passion for growing a business.
  • Solution‑oriented, flexible, and agile with the ability to move quickly, pivot when needed, manage multiple priorities, and meet deadlines in a fast‑paced work environment.
  • Cultural sensitivity and demonstrated success in navigating a large and matrixed global organization.
  • Excellent verbal and written communication skills, including outstanding presentation skills, with the ability to deliver clear and concise guidance and instructions.
  • Excellent qualitative and quantitative analytical skills to identify and solve a wide range of business problems.
  • Ability to interact and partner effectively with senior management and associates at all levels within the organization.
  • Ability to implement effective compliance programs alongside business objectives.
  • Strong attention to detail and strong organizational skills.
  • Ability to effectively manage conflict and other challenging situations.
  • Reputation for the highest integrity and ethical standards.
Physical Requirements and Work Environment

This role requires the ability to perform standard office activities, including extended periods of computer use, participation in virtual and in‑person meetings, and collaboration across teams. Depending on business needs, occasional travel may be required. Work environments and physical requirements may vary based on the requirements of the role. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.

Compensation

The target base salary range for this role is $169,600,000-$212,000 per year. This range reflects the anticipated compensation for the role. Where pay falls withing the range may vary based on many factors, including, but not limited to, job responsibilities, skills, experience, education, certifications, location and applicable geographic pay zones, market conditions, internal equity and business considerations. Compensation decisions are made based on an assessment of the candidate’s qualifications and the totality of relevant factors.

Benefits

Galderma offers a competitive and comprehensive benefits program, including medical, dental, and vision coverage, a 401(k) plan with employer match, paid time off, and other benefits, subject to eligibility and applicable plan terms.

Work Authorization

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.

What We Offer

At Galderma, you’ll be part of a purpose-driven organization committed to advancing dermatology and improving patient outcomes worldwide. We offer competitive compensation, annual incentive opportunities, and comprehensive benefits, along with meaningful opportunities for growth, development, and collaboration in an inclusive and innovative environment.

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast‑growing dermatology market through Injectable Aesthetics, Dermatological Skincare 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 are in shapes our lives, we are advancing dermatology for every skin story. For more information go to www.galderma.com/careers

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