Senior Director - Labeling and Operations

Senior Director - Labeling and Operations

About Pharming

Pharming Healthcare 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 act with urgency

• We get it done

• We make it simple

Our Vision

Our Vision is to develop a leading global rare disease company with a diverse portfolio and presence in large markets, leveraging proven and efficient clinical development, supply chain, and commercial infrastructure.

Life at Pharming

Today, more than ever, we're positioned to realize our vision of becoming a leading global rare disease company. Our success will come from everyone's commitment to our patients, our ability to work with focus and clarity, and our shared dedication to building something meaningful together. We can only achieve this by embracing our biotech culture, Life at Pharming, which is dynamic, experimental, and shaped by what we learn together.

Summary

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.

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.

Qualifications

• 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

Salary Range

Pharming takes into consideration a combination of candidate's work experience, training, and education, as well as the scope of the role, complexity, and external market and internal value when determining a salary level.

The base salary range for this job is from $230,000 to $290,000 per year.

Compensation & 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

Other Benefits

• 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

Additional Information

Pharming Healthcare, Inc. is a merit-based equal opportunity employer. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected classes.

An applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request via email to [email protected] .

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 source. Pharming will only pay a fee to agencies if a formal agreement between Pharming and the agency has been established. The Human Resources/Talent Acquisition department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.