Senior Director Regulatory Affairs

Description Overview

Support the Perrigo Over-the-Counter (OTC) Business Unit through strategic leadership of staff responsible for the hands-on regulatory activities associated with bringing new Brand and Store Brand products to market and maintenance of commercialized products for US and Canadian product categories including New Drugs, Abbreviated New Drugs, Medical Devices, Dietary Supplements, Natural Health Products, and Cosmetics.  Additionally, provide strategic regulatory guidance to Marketing and Business Development staff in developing growth strategies to enter new business segments, product categories, technology and inorganic acquisitions in support of the OTC Business Unit.  

Scope of the Role

1.Confirm that project plan due dates are consistent with regulatory strategy
2. Work directly with Regulatory Agencies to resolve regulatory issues
3.  Direct and manage contacts with outside consultants to resolve regulatory issues
4.  Represent regulatory affairs in leadership meetings
5.  Ensure appropriate basis to marketing strategies are identified and/or implemented; Identify and employ advanced regulatory strategies
6.  Communicate and collaborate with cross-function OTC management staff
7.  Support and lead a continuous improvement environment
8. Provide oversight for OTC RA processes and systems
9.  Hire, train and evaluate performance of direct reports
10.  Manage and prioritize OTC RA resources
11.  Manage projects as assigned by CSCA VP of RA or OTC business unit leader
12.  Work directly with FDA, Health Canada, trade associations and outside regulatory and legal experts to influence emerging legislation, regulations, guidances and FDA decision making on matters material to Perrigo OTC BU with support from CSCA RA VP
13.  Develop strategies and tactics to support first to market commercial opportunities and minimize time to product launch
14. Mentor staff to maximize the leadership talent pool

Experience Required

1.  Must demonstrate advanced analytical skills, the ability to identify and apply policies and general regulations to specific products or projects and create new policies as required
2.  Ability to monitor, analyze, raise awareness, and assess impact of regulatory issues for executive stakeholders inside and outside of Regulatory Affairs
3.  Advanced verbal and written presentation and communication skills are necessary 
4.  Ability to utilize advanced business and financial acumen in decision making 
5. The ability to effectively lead cross-functional management-level teams is required
6.  Advanced knowledge of scientific, regulatory, and legal terminology is necessary 
7.  These skills are normally acquired through possession of a bachelor’s degree in a health sciences field such as biochemistry, chemistry, pharmacy, pharmacology combined with 10+ years of experience in the health care or pharmaceutical industry and 10-12+ years of hands-on experience in regulatory affairs  
8.  10 or more years of experience in direct supervision
9.  Advanced degree preferred