The Manager, Global Marketing Compliance serves as the Regulatory Affairs (RA) representative on product promotion review teams. 

They will be responsible for reviewing and approving the regulatory content of international materials created for product promotion, disease awareness, and public affairs communications in the EU and markets outside of the US and Japan. They will also engage with business partners for strategic planning on issues pertaining to product promotion and will participate in developing processes and procedures relevant to the creation, review, and approval of promotional materials. This person will also act as the primary liaison with local regulatory leads, especially in the EU and Canada, to support regulatory issues concerning promotional materials.

Responsibilities
 

• Reviews global marketing, disease awareness, public affairs, and medical materials, attend marketing review meetings and provides regulatory guidance to the cross-functional team responsible for ensuring material compliance with global compliance standards and regulations pertaining to prescription drug marketing, as applicable
• Serves as primary contact for the review of promotional materials in the International region.
• As needed, provides training support within the company on regulatory requirements for prescription drug promotion including, but not limited to, sales training and compliance training in preparation for scientific conferences
• In collaboration with their Senior Manager in the Global Marketing Compliance team, will provide advice to product development teams on advertising and promotion issues to facilitate the strategic development of new products
• Ensures stakeholder awareness of proposed and newly approved labeling changes
• Provide guidance to global medical-legal regulations to ensure appropriate implementation and reflected in assigned product SmPC and promotional materials in a timely manner

Requirements
 

• Bachelor’s degree in science or pharmacy
• 2 -5 years of relevant experience in the EU region
• Direct experience communicating and negotiating directly with regulatory agencies is helpful
• Experience with global standards for marketing compliance
• Proven track record practicing sound judgment as it relates to risk assessment
• Knowledgeable of industry compliance requirements and non-compliance examples and trends
• Demonstrated ability to influence others and encourage team collaboration
• Strong interpersonal, communication, and leadership skills.
• Proven ability to prioritize and meet critical business timelines
• Fluent in local market language and excellent English, written and oral

Desired
 

• Bachelor’s in Pharmacy, PharmD or master’s degree preferred