A track record of 20+ years of increasing responsibility and experience within the pharmaceutical industry: I have developed a reputation for positive & effective customer (internal/external key stakeholders - KOIs ) engagement, fostering acceptance of organizational change, and catalyzing next-level team performance. As an emotionally intelligence leader, I possess an unusual blend of scientific, business analysis, and problem-solving skills with a gift for cultivating talent in those around me, as these achievements from my tenure at Pfizer demonstrate:
- Consumer/Patient Engagement (Voice of the Customer)
- Rx-OTC Switch (Actual Use & Consumer Behavior Studies/Simulation)
- Regulatory Science, Education & Intelligence
- - Global/US Regulations & Policies
- FDA/BoH Interactions
- People Management
- Preceptor/Pharm D Research Fellowship Program (Rutgers)
- Due Diligence
- Post-Acquisition Integration
- Innovation Culture Engagement
- Process/SOPs/Performance Improvement
US Regulatory Strategy Group Lead (Director) @ -Oversee US Regulatory Strategy Registered Products (+1 Billion Dollars Revenue of Consumer Healthcare Portfolio)
- Drive Innovative Regulatory Strategies for all US NDA/OTC drugs
-Rx-to-OTC Switch work (consumer behavioral studies)
-PCH Representative on CHPA Regulatory & Scientific Advisory Committee and Planning Committee for association meeting(s)
-Regulatory Intelligence/Policy engagement for nonprescription regulation/legislation
-Preceptor of research fellowship program with Rutgers University School of Pharmacy
-Appointed to co-lead strategic planning to optimize global regulatory organization for people development/talent/retention
-Due diligence in-licensing/M&A
-Pfizer Consumer Division lead for Cross-BU initiatives for harmonization of systems/procedures;
-People management From December 2013 to Present (2 years 1 month) Director, Global Strategy Lead @ -Appointed to Strategic Planning Team to optimize global regulatory organization
-Cross-divisional integration to promote knowledge-sharing and best practices of regulatory science
-Conduct routine regulatory intelligence and policy surveillance
-Global Regulatory Lead for Respiratory and Personal Care in franchise governance body chartered to promote product development for global market penetration.
-Due diligence regulatory lead for in-licensing/M&A for Division
-Pfizer Consumer Division lead for Cross-BU initiatives for harmonization of systems/procedures;
-Appointed Chief Engagement Officer for HQ Consumer Site to promote an agile culture and increased engagement. From February 2013 to December 2013 (11 months) North America (US) Regulatory Strategy- OTC Medicines @ Oversee regulatory strategies and compliance for Rx-to-OTC switch products. Contribute to product innovation, ideation and franchise development. Conduct due diligence on in-licensing opportunities; perform gap analysis on cross-divisional processes & procedures, develop training tools for enterprise/platform functions, educating key stakeholders on regulatory environment and industry trending. From January 2012 to February 2013 (1 year 2 months) North America (US & Global) Regulatory Strategy - Dietary Supplements @ **Developed and led implementation of US regulatory strategies as FDA SME.
** Team- & Morale-Building: Strengthened employee morale and multifunctional collaboration, initiating, planning, and implementing cross-divisional strategic change initiatives.
** STAFF RECOGNITION: Formulated and rolled out staff recognition programs impacting an organization of 30+ personnel by building, mentoring, and motivating peer leadership teams.
** CHANGE MANAGEMENT: Recognized for exhibiting Innovation Behavior for fostering playfulness, catalyzing creativity, and cultivating openness to change. Recognized by peers and senior management as cross-functional camaraderie champion.
** STAFF TRAINING: Spurred like-minded intradepartmental unity events across multiple business units. Facilitated site-wide workshop on discovering strengths and talents via StrengthFinder process.[a] From 2010 to January 2012 (2 years) Sr. Manager, US Strategist @ From 2009 to 2012 (3 years) Senior Manager – Global Regulatory CMC @ ** Resolved regulatory issues for product development programs.
** PROCESS IMPROVEMENT: Streamlined workflow in the aftermath of Lean Six Sigma changes, designing divisional web resource and computer-based training module. Reduced rework while enhancing market and health awareness among 10,000 daily website visitors.
** CUSTOMS COMPLIANCE: Set the stage for Pfizer’s first-in-market success with web-based repository. Trained team in drug listing system and guided completion for 500 SKUs and 60 products with 100% FDA compliance.
** PRODUCT MARKETING: Played a key role in the development and launch of Pfizer’s nutrition and healthy living social media platform and balanced FDA compliance with online and mobile app evolution as in-house expert.
** ACQUISITION INTEGRATION: Streamlined Wyeth acquisition leading playbook design to standardize process execution and improve efficiency.
** REGULATORY TRAINING/ONBOARDING: Served as Lead Trainer on compliance and drug development issues and steered the translation, adaptation, and execution of e-learning resources. From March 2007 to April 2009 (2 years 2 months) Sr. Regulatory Associate - EMEA Liaison @ Managed product registrations and lifecycle maintenance for consumer products within EMEA region. From 2004 to 2007 (3 years) Sr. Manager, Regulatory Affairs @ Developed, oversaw, and approved regulatory documentation for submissions to global health authorities.
BUSINESS DEVELOPMENT:Paved the way for Genta’s acquisition of orphan drug and reinstatement of application, spearheading intellectual property data mining effort. From 2002 to 2004 (2 years) Microbiologist/Vaccine Research/International Regulatory Affairs @ **International Regulatory Liaison for therapuetic areas: GI, NSAIDs, CNS and CV/CHL
**Bioprocess R&D emphasis in fermentation/pilot plant scale up operations, screening of stereoselective enantiomers etc.
**Vaccine Research included BL2/3 viral assay development for clinical study batches for use in Phase 2 clinical trials From 1995 to 2002 (7 years)
(2) Bachelor of Science (B.S.), Biochemistry & Nutritional Sciences @ Rutgers, The State University of New Jersey-New Brunswick From 1992 to 1995 Christine Chirdo is skilled in: Lifestyle Coaching, Organizational Development, FDA, USDA & EMEA Regulations, Lean Six Sigma Yellow Belt, Change Control Management, Acquisition Due Diligence, In-licensing, Contract Negotiations, Technical Writing & Editing, Digital & Social Media, Multicultural Communications, Staff Development & Coaching, Social Responsibility, Global Project Management, New Business Development