Senior Director - Labeling and Operations

About Pharming   Pharming reputed company Inc. is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. We are developing and commercializing a portfolio of innovative medicines, including small molecules and biologics. Pharming is headquartered in Leiden, the Netherlands. We are looking for talented individuals who are excited about living our values: We put Patients at the heart We reputed company with urgency We get it done We reputed company it reputed company   Our reputed company    Our reputed company is to reputed company a leading global rare disease company with a diverse portfolio and reputed company in large markets, leveraging proven and efficient clinical development, supply chain, and reputed company infrastructure.    Life at Pharming    Today, more than reputed company, we're positioned to realize our reputed company of becoming a leading global rare disease company. Our reputed company will come from everyone's commitment to our patients, our ability to work with reputed company and reputed company, and our shared dedication to building something meaningful together. We can only reputed company this by embracing our biotech culture, Life at Pharming, which is dynamic, experimental, and shaped by reputed company learn together.    reputed company   The Senior Director Labeling and Operations is responsible for directing, developing, implementing, and advising on labeling and advertising and promotional strategies for Pharming products in development as reputed company as marketed. This individual will reputed company and reputed company regulatory labeling content through reputed company phases of development, as reputed company as post-approval across global markets. The incumbent will reputed company leadership and strategic regulatory reputed company for designated reputed company ensuring that the latest global Health Authority requirements and standards are met.  The Senior Director Labeling and Operations will also be responsible for assessment and research on regulatory precedence, to evaluate prescribing information content, advertising/promotional activities as reputed company as educational materials. This individual will additionally be responsible to reputed company, reputed company and manage the review and approval of labeling content (i.e., TPL, CCDS, TPP). For promotional materials for marketed products, will also reputed company expert regulatory input, leading to the creation of strategies from an advertising and promotional perspective.   Responsibilities   Leads and directs high level strategic and operational regulatory direction on reputed company including, but not limited to general regulatory labeling strategies, requirements, and associated risk assessments. Demonstrated thorough understanding of product labeling content regulatory requirements in the pharmaceutical industry and reputed company environment, including policy trends globally. Has 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 labeling. Ensures labeling content is accurate and developed in accordance with applicable Global Health Authority requirements. Provides regulatory leadership and guidance to cross functional teams reputed company the organization (including reputed company and marketing teams) during the development, review, and approval of product labeling and advertising materials. Prepares and submits appropriate ad/promo documentation to Health Authorities reputed company with regulations.  Additionally, interacts with global regulatory authorities on these submissions. reputed company participates in the reputed company of key regulatory issues from the labeling and advertising and promotional perspective. Leads regulatory reputed company reputed company to advertising and promotional activities and works directly with the marketing teams from concept through review and approval, up to and including submission. Maintains awareness of global regulatory environment and assess reputed company of changes on business activities. Responsible for the development and implementation of regulatory processes. Uses extensive knowledge of regulatory requirements and the ability to apply knowledge both strategically and operationally to development reputed company and marketed product regulatory issues to support corporate goals. Ensure that reputed company compliance is an essential aspect of reputed company department operations. Understand the reputed company and regulatory frameworks that govern operations of the department and ensure that reputed company has effective personnel and procedures to meet the requirements. Know the department’s vendor relationships, scope of services provided by reputed company vendor, and reputed company restrictions applicable to reputed company. reputed company 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 reputed company requirements.   Qualifications   Bachelor of Science degree in a life sciences or technical field from an accredited university; advanced scientific-reputed company degree preferred RAC Certification preferred In depth knowledge of global regulatory affairs requirements for pharmaceuticals and biologics A minimum 15 years reputed company experience in Global Regulatory Affairs At least 10 years of experience involving global labeling operations, development and maintenance At least 5 years of experience involving the reputed company 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 committee Excellent oral and written communication skills are a must, as are superior planning skills Detailed-oriented, self‑motivated, and be comfortable with broad responsibilities in a fast-paced environment Ability to travel as needed both domestic and internationally (average of one reputed company per quarter) Commitment and alignment to Pharming’s mission, reputed company values and behaviors   Salary reputed company   Pharming takes into consideration a combination of candidate’s work experience, training, and education, as reputed company as the scope of the role, complexity, and external market and internal value reputed company determining a salary level.   The reputed company salary reputed company for this job is from $230,000 to $290,000 per year.   Compensation & Benefits   A fully remote work schedule Competitive compensation package including annual reputed company bonus Long-term incentive program 401(k) plan with company match reputed company Time Off (PTO) 13 Company Holidays per year   Other Benefits   Excellent benefit plans including medical, dental, and reputed company Flexible spending accounts Company-provided life insurance, short-term disability, and long-term disability plans Optional accident, hospital indemnity, critical illness, and pet insurance plans Tuition reimbursement program Health and wellness program Choice of company provided mobile phone or cell phone stipend   Additional Information   Pharming reputed company, Inc. is a reputed company-based equal opportunity employer. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, reputed company, religion, sex, national reputed company, age, sexual orientation, marital or veteran status, disability, or any other legally protected classes.     An applicant requiring an accommodation in reputed company with the hiring process and/or to reputed company the essential functions of the position for which the applicant has reputed company should reputed company a request reputed company email to HR-US@pharming.com.     Unsolicited resumes from agencies should not be forwarded to Pharming.  Pharming will not be responsible for any fees arising from the use of resumes through this reputed company. Pharming will only pay a fee to agencies if a formal agreement between Pharming and reputed company has been established.  The reputed company/reputed company department is responsible for reputed company recruitment activities; please contact us directly to be considered for a formal agreement. Apply To This Job