Pharming Group · 2 weeks ago
Senior Director - Labeling and Operations
United States
Full-time
Remote
Director/Executive
$230K/yr - $290K/yr
15+ years expPharming Healthcare Inc. is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. The Senior Director Labeling and Operations is responsible for directing and implementing labeling and advertising strategies for Pharming products, ensuring compliance with global Health Authority requirements and leading cross-functional teams in the development and approval of regulatory content.
Biotechnology
Responsibilities
Leads and directs high level strategic and operational regulatory direction on projects 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 healthcare 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 within the organization (including commercial 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 aligned with regulations. Additionally, interacts with global regulatory authorities on these submissions
Actively participates in the resolution of key regulatory issues from the labeling and advertising and promotional perspective
Leads 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 submission
Maintains awareness of global regulatory environment and assess impact 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 projects and marketed product regulatory issues to support corporate goals
Ensure that legal compliance is an essential aspect of all department operations
Understand the legal and regulatory frameworks that govern operations of the department and ensure that the company has effective personnel and procedures to meet the requirements
Know the department’s vendor relationships, scope of services provided by each vendor, and legal restrictions applicable to each
Provide 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 requirements
Qualification
Required
Bachelor of Science degree in a life sciences or technical field from an accredited university; advanced scientific-related degree preferred
In depth knowledge of global regulatory affairs requirements for pharmaceuticals and biologics
A minimum 15 years related 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 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 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 trip per quarter)
Commitment and alignment to Pharming's mission, core values and behaviors
Preferred
RAC Certification preferred
Benefits
A fully remote work schedule
Competitive compensation package including annual target bonus
Long-term incentive program
401(k) plan with company match
Paid Time Off (PTO)
13 Company Holidays per year
Excellent benefit plans including medical, dental, and vision
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
Company
Pharming Group
Pharming Group is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Anurag Relan
Chief Medical Officer
Stephen Toor
Chief Commercial Officer
Company data provided by crunchbase