Senior Director - Labeling and Operations
About The Position
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 well as marketed. This individual will lead and direct regulatory labeling content through all phases of development, as well as post-approval across global markets. The incumbent will provide leadership and strategic regulatory oversight for designated projects 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 well as educational materials. This individual will additionally be responsible to lead, develop and manage the review and approval of labeling content (i.e., TPL, CCDS, TPP). For promotional materials for marketed products, will also provide expert regulatory input, leading to the creation of strategies from an advertising and promotional perspective.
Requirements
- Bachelor of Science degree in a life sciences or technical field from an accredited university; advanced scientific-related degree preferred
- RAC Certification 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
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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
