[Remote] Senior Director - Labeling and Operations Job Details | Pharming Group N.V.

Note: The job is a remote job and is open to candidates in USA. Pharming Healthcare, Inc. is a global biopharmaceutical company dedicated to transforming the lives of patients with rare diseases. The Senior Director of Labeling and Operations is responsible for directing and implementing labeling and promotional strategies for Pharming products, ensuring compliance with global regulatory standards throughout all phases of product development.ResponsibilitiesLeads and directs high level strategic and operational regulatory direction on projects including, but not limited to general regulatory labeling strategies, requirements, and associated risk assessmentsDemonstrated thorough understanding of product labeling content regulatory requirements in the pharmaceutical industry and healthcare environment, including policy trends globallyHas extensive regulatory experience leading and managing the development and maintenance of product labeling, and associated review processes by managing the preparation and revision of regional labelingEnsures labeling content is accurate and developed in accordance with applicable Global Health Authority requirementsProvides regulatory leadership and guidance to cross functional teams within the organization (including commercial and marketing teams) during the development, review, and approval of product labeling and advertising materialsPrepares and submits appropriate ad/promo documentation to Health Authorities aligned with regulations. Additionally, interacts with global regulatory authorities on these submissionsActively participates in the resolution of key regulatory issues from the labeling and advertising and promotional perspectiveLeads regulatory oversight related to advertising and promotional activities and works directly with the marketing teams from concept through review and approval, up to and including submissionMaintains awareness of global regulatory environment and assess impact of changes on business activitiesResponsible for the development and implementation of regulatory processesUses extensive knowledge of regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goalsEnsure that legal compliance is an essential aspect of all department operationsUnderstand the legal and regulatory frameworks that govern operations of the department and ensure that the company has effective personnel and procedures to meet the requirementsKnow the department’s vendor relationships, scope of services provided by each vendor, and legal restrictions applicable to eachProvide for procedure and guidance development, training, monitoring and reporting to ensure internal controls of company operations and vendor controls of vendor operations ensure adherence to legal requirementsSkillsBachelor of Science degree in a life sciences or technical field from an accredited university; advanced scientific-related degree preferredIn depth knowledge of global regulatory affairs requirements for pharmaceuticals and biologicsA minimum 15 years related experience in Global Regulatory AffairsAt least 10 years of experience involving global labeling operations, development and maintenanceAt least 5 years of experience involving the direct implementation of promotional labeling and advertising regulations in the biotech/pharmaceutical industry globally; this must include experience providing regulatory input and evaluation as part of a promotional review committeeExcellent oral and written communication skills are a must, as are superior planning skillsDetailed-oriented, self‑motivated, and be comfortable with broad responsibilities in a fast-paced environmentAbility to travel as needed both domestic and internationally (average of one trip per quarter)Commitment and alignment to Pharming's mission, core values and behaviorsRAC Certification preferredBenefitsA fully remote work scheduleCompetitive compensation package including annual target bonusLong-term incentive program401(k) plan with company matchPaid Time Off (PTO)13 Company Holidays per yearExcellent benefit plans including medical, dental, and visionFlexible spending accountsCompany-provided life insurance, short-term disability, and long-term disability plansOptional accident, hospital indemnity, critical illness, and pet insurance plansTuition reimbursement programHealth and wellness programChoice of company provided mobile phone or cell phone stipendCompany OverviewOverview Pharming is a specialty pharmaceutical company developing innovative products for the safe, effective treatment of rare diseases and unmet medical needs. It was founded in 1988, and is headquartered in Leiden, Zuid-Holland, NLD, with a workforce of 51-200 employees. Its website is https://www.pharming.com.