Director/Senior Director, Regulatory Advertising and Promotion Position Available In New York, New York

ResponsibilitiesProvides strategic regulatory advice on promotional materials and activities related to Stemline brands in accordance with business objectives, company policy, and FDA Guidances and regulations.

Provides specialized knowledge on region/country regulations and requirements governing product promotion and related communications, including pipeline and disease state communications.

Maintains current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policy issues and trends affecting the pharmaceutical/biologics industry. Communicates significant changes in FDA perspective to relevant stakeholders.

Serves as regulatory reviewer for assigned product(s) on Promotional Review Committee (PRC).As a regulatory reviewer, assesses the regulatory context and provide regulatory interpretations of applicable guidance and/or regulations or regulatory precedents, including requirements related to submission of material to Health Authority (HA) and interact with HA, as applicable.

In conjunction with US RA department leadership team; proactively identifies and designs improvement opportunities to reduce compliance risk and increase efficiency and effectiveness in Regulatory Affairs.

Participate in development, implementation and maintenance of regulatory policies and procedures.

Provides direction and works collaboratively to ensure that changes in product labeling are carried into promotional materials in accordance with company procedures and regulatory requirements.

Collaborates in cross-functional efforts to develop and update procedures and guidelines related to PRC processes.

Creates and/or maintains Important Safety Information (ISI) for HCPs, consumers, and public relations. Plans and conducts training sessions as needed with stakeholders.

Coordinates the development and implementation of regulatory strategies for promotion and advertising plans and is a leader in the Medical, Legal and Regulatory Review process to support approval and dissemination of marketed product and disease state promotional material. Reviews external communications materials, sales and marketing materials, including training, for compliance with current regulations and guidance.

Participates in training for sales and marketing on advertising and promotional material.

Represents the company to outside customers and agencies and makes presentations as needed on current regulatory issues pertaining to advertising and promotional activities.

Sets clear objectives and consistently delivers while demonstrating full accountability for functional area results.

Assist the Regulatory Leadership Team with financial and budgeting support for annual and long-range planning.

Provide expertise while participating in assigned corporate leadership initiatives in various aspects of business process improvement.

QualificationsBachelor’s degree in life sciences, pharmacy, or related field. Advanced degree preferred.

Minimum of 10 years of experience in regulatory affairs, with at least 5 years in advertising and promotion complianceExpert knowledge of US laws, regulations, and guidance documents related to pharmaceutical advertising and promotion. Familiarity with global regulations and standards is a plus.

Experience communicating and negotiating directly with OPDP and performing risk assessment.

In-depth understanding of clinical study design and statistical analyses in assessment of promotional claimsAbility to assess & communicate risk/benefit to senior management and influence organizational direction as it pertains to compliant advertising and promotion materials.

Demonstrated problem solving abilities and conflict resolution skills.

Excellent verbal and written organizational and communication skills; Experience influencing and communicating policy issues.

Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization.

Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.

Must be detail-oriented, decisive, and capable of influencing individuals and managing teams while demonstrating leadership, flexibility, and strong communication skills. Menarini Stemline is committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions

Minimum Salary:

200,000

Maximum Salary:

280,000

Salary Unit:

Yearly