Represent Regulatory Affairs on Early Development Teams for emerging products. Coordinate regulatory submission activities to ensure timely continuation of ongoing clinical trials and new global trials. Provide regulatory strategy clinical development plans.

Responsible for managing, designing, and implementing the US regulatory strategy as part of a global team for the successful development of clinical-stage programs, with guidance from the Vice President and Senior Directors, Regulatory Affairs & Global Development Projects. Function as the primary contact for negotiations and interactions with the FDA and offer guidance and strategy for US and ex-US regulatory filings. Contribute to developing regulatory strategies to ensure the shortest FDA review and approval times for regulatory applications. Provide regulatory guidance to team members regarding regulatory requirements for IND and NDA/sNDA submissions. Coordinate and consult with other departments on the content, review, and assembly of regulatory documentation.

Provided strategic regulatory guidance as a Senior Consultant to cross-functional project teams responsible for product development, actively leading development and implementation of regulatory strategy for assigned programs.• Defined and implemented global regulatory strategies in a number of therapeutic areas (nervous system, cardiovascular, skin disorders)• Helped coordinate all aspects of regulatory submissions relevant to assigned programs• Participated as a key member of Global Regulatory Project Teams• Participated as Chairperson of Regulatory Intelligence Subcommittee with Japan and UK

Provided regulatory leadership and assistance as a Contracted Regulatory Project Manager for assigned diabetes drug product projects, working independently and as part of the Project Team. • Contributed to the preparation and delivery of regulatory operational plans for allocated projects and contributed to solutions to ongoing regulatory issues.• Project managed quality regulatory submissions to agreed project targets, working with global regulatory affairs personnel and global/regional cross-functional teams.• Provided regulatory research and intelligence to the diabetes team concerning ongoing and project-related regulatory issues and requirements; identified potential regulatory risks to the operational plan and proposed options to mitigate risks.

Provided regulatory leadership as Project Manager for assigned anti-inflammatory projects, independently and as a Project Core Team member.* Developed positive and productive relations with key stakeholders in Denmark and Princeton to create action plans and achieve business objectives.* Developed key regulatory submission strategies, including White Papers on key development concepts for rheumatoid arthritis drugs.* Worked effectively with DK/U.S./worldwide affiliate associates and CROs to assure complete coverage of project requirements and compliance with internal SOPs and US/International regulatory requirements; mentored fellow Project Leaders on previous projects before taking on new project responsibilities.* Directed strategic development and submission of required documents to regulatory agencies, including U.S. and worldwide. Attended extended Business Trip to Denmark (May-June 2013) as Project Manager for two anti-inflammatory compounds.* Served as Project Manager and Core Team member for three anti-inflammatory compounds. Played an important role to assure Project Team preparation for a pre-IND meeting with FDA.* Established and led multi-discipline Rapid Response Team to handle CTA queries for a development anti-inflammatory compound.* Led project to update the Novo Nordisk process for Agency Meetings, with Project Team members in Copenhagen and Princeton; author of “Supporting Guidance on Good Regulatory Meeting Practice with Regulatory Authorities.”

Provided regulatory leadership for Pfizer's antimicrobial drug products and support for the Established Products Business Unit portfolio in Emerging Markets, including anti-infectives and hospital products, for South America, Africa, Middle East, Eastern Europe, and Asia.• 2009 Pfizer PGRD Team Award, Member Antibacterials Research Unit Pharmacokinetic/Pharmacodynamic Agile Team (2009).• Led preparation of numerous IRD/CTD dossiers for Emerging Markets countries.• Recognized as Emerging Markets and Japan Infectious Disease Subject Matter Expert.• Co-Chair of PhRMA/Industry Antibiotic Task Group/Limited Duration-Key Issue Team representing all PhRMA antimicrobial manufacturers.

U.S. Infectious Disease Regulatory Leader, responsible for Worldwide Regulatory Strategy and NDA and IND filings for the Infectious Disease Therapeutic Area. Co-chair of PhRMA/Industry Antibiotic Task Group.• Co-Representative of the Year for Drug Delivery Technology Steering Committee (2002).• Member of Early Candidate Management Team of the Year – Antimicrobial Drug Team (2002).• Partnered with Pfizer Japan Regulatory and Marketing in support of J-NDA filings for a number of anti-infective compounds; included an assignment in Tokyo, resulting in a successful re-submission for Azithromycin (2002).• 2001 Member of Outstanding ECMT – Azithromycin Team (2001).• Served as U.S. Infectious Disease Regulatory Leader, responsible for Worldwide Regulatory Strategy and NDA + IND filings for the Infectious Disease Therapeutic Area. (1995 – 2011).• Organized and served as Co-Chair of the PhRMA/Industry Antibiotic Task Group/Limited Duration-Key Issue Team representing all PhRMA antimicrobial manufacturers; helped organize 3 antimicrobial issue meetings held between PhRMA and FDA management. (1998 – 2011).• Led regulatory activities leading to the following US FDA submissions and approvals:- Zmax Pediatric CAP – sNDA submission and approval (October 7, 2008).- Zmax Adult – NDA submission and approval (June 10, 2005).• Helped develop advertising and promotion pieces for Zmax and Zithromax submissions to FDA.• Served as a Regulatory representative for Pfizer’s R&D facility in England, including a successful CBER IND submission for a stroke compound. (1998 – 2008).

Directed regulatory activities for the anti-infective program, including a successful NDA submission.• Served as Regulatory representative responsible for primary interactions with CBER (1996 – 2008).• Led regulatory activities leading to the following US FDA submissions and approvals:- Anti-infective Trovan – NDA submission and approval (December 18, 1997).- Prepared/submitted IND’s for two anti-infective compounds.- Numerous CMC submissions.• Established first Regulatory Rapid Response Team (RRT) in Pfizer Central Research (1997).

Directed all aspects of North American and assisted in International regulatory efforts for Bayer’s anti-infective drug products (including ciprofloxacin) in association with Bayer AG. Represented Regulatory Affairs on Development Project Teams for new and existing drugs.• Directed preparation of successful IND, NDA, SNDA, and labeling, advertising, and promotion submissions for Bayer’s existing and new anti-infective drug products (including two new indications for ciprofloxacin). • Liaison to Marketing, Sales, Clinical, and Project Management to coordinate activities for anti-infective products.• Worked with Marketing to develop innovative advertising copy. Directed the review of labeling, advertising, and promotion materials to assure compliance with Regulatory requirements.