Interface with internal staff and development partners to establish and manage processes and procedures to ensure alignment of global product advertising, promotion and labeling for various regions (focus US, oncology). Influences teams for assigned products and projects to implement compliant product labeling and communications.
Key Accountabilities/Core Job Responsibilities:
Develop and implement processes and procedures related to the review/approval of local advertising and promotional materials and alignment of global product labeling.
Collaborate with and influence local regional regulatory representatives to assure local or regional labeling aligns with Company Core Data Sheet (CCDS) or other reference labeling
Review and approve core global materials as assigned and ensure messaging is consistent with CCDS to ensure compliance with applicable US regulations/requirements
Provide educational training for local regulatory staff, contractors and others regarding company policies and procedures within the scope of the Global Regulatory Affairs Advertising, Promotion, and Labeling group.
Provide general Regulatory Affairs management role for registrational, international studies and manage CRO staff in regulatory operations of study start up, conduct and study conclusion.
Responsible for leading all interactions with the FDA Office of Product and Drug Promotion
Excellent project management skills with the ability to work on assigned projects within timelines. Great attention to detail and ability to interpret clinical and scientific data.
Excellent verbal and written communication skills. Ability to represent regulatory in cross-functional teams. Strong interpersonal skills and ability to work in a small/medium size company setting
Internal and External Contacts
Candidate will serve as the lead contact for Pharmacyclics on all labeling matters and work closely with our Partner Janssen Pharmaceutical to implement and align on global promotional strategies and material. This position requires frequent contact with colleagues in commercial, medical, legal, corporate communications, regulatory, and other product team members within Pharmacyclics and Janssen.
Knowledge of international regulations and regulatory guidance specific to advertising, promotion and labeling of pharmaceutical products
Candidate to assist with additional regulatory projects as needed.
Education Requirements (degree, certifications, etc.):
BA/BS, advance allied health degree preferred (such as MS, PhD, PharmD, foreign MD).
Minimum of 5 years of relevant Regulatory experience in the pharmaceutical/biotechnology industry.