Hiring: Associate Director Regulatory Affairs (Labeling) Company: Hays Location: Greater Boston Job Posted Time: 2026-09-10 11:53:36 Target Skills & Keywords : Regulatory Compliance About the job Experience: •Bachelor's degree with a minimum of 12 years of experience, Master's degree with a minimum of 8 years of experience, or PhD with a minimum of 5 years of experience in Regulatory Affairs, Labeling, Advertising & Promotion, or a closely related discipline within the pharmaceutical, biotechnology, or medical device industry. •12 years of experience, Master's degree with a minimum of 8 years of experience, or PhD with a minimum of 5 years of experience in Regulatory Affairs, Labeling, Advertising & Promotion, or a closely related discipline within the pharmaceutical, biotechnology, or medical device industry. Required Skills: •Review, approve, and provide regulatory oversight for product labeling, advertising, promotional materials, and other commercial communications to ensure compliance with applicable FDA regulations, CFR requirements, company policies, industry standards, and other relevant regulatory requirements. •Lead and manage promotional review processes and associated operational systems, including Veeva Vault PromoMats, electronic document management systems, workflows, SOPs, and governance processes supporting the review and approval of commercial materials. •Prepare, compile, and coordinate required regulatory submissions for promotional materials, including FDA Form 2253 submissions, in collaboration with Regulatory Operations. •Develop and implement regulatory labeling and promotion strategies for new, existing, and modified products, ensuring alignment between approved labeling, promotional messaging, and business objectives. •Review and approve labeling, promotional claims, and marketing content to ensure scientific accuracy, claim substantiation, fair balance, appropriate risk communication, and consistency with approved prescribing information and regulatory commitments. •Actively facilitate and support development, maintenance, and implementation of product labeling, claims support documentation, and regulatory records, ensuring materials remain current with approved indications, safety information, regulatory changes, and business needs. •Assess evolving regulations, guidance documents, enforcement actions, and industry trends and provide recommendations regarding their impact on labeling, advertising, promotion, and commercial practices. •Develop and document regulatory positions, risk assessments, and compliance recommendations that support sound business decisions while maintaining regulatory compliance. Qualifications: •Able to interpret regulations / guidelines / standards and make appropriate judgments on what requirements are applicable to products •Able to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors and translate that complexity into clear recommendations and solutions •Demonstrated capacity to adapt to a quickly changing environment. •Demonstrated capacity to effectively communicate issues and ideas with peers and with management. •Demonstrated capacity to organize and lead meetings with cross functional teams. •Demonstrated interpersonal, written, and oral communication skills. •Demonstrated capacity to build effective working relationships throughout the organization. Compensation: •$180,000 - $215,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!