Perrigo

　　Senior Director Regulatory AffairsLocation: Grand Rapids, MI, US, 49503#job-location.job-location-inline {display: inline;}Perrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it.External applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.Description OverviewSupport 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 Role1.Confirm that project plan due dates are consistent with regulatory strategy2. Work directly with Regulatory Agencies to resolve regulatory issues3. Direct and manage contacts with outside consultants to resolve regulatory issues4. Represent regulatory affairs in leadership meetings5. Ensure appropriate basis to marketing strategies are identified and/or implemented; Identify and employ advanced regulatory strategies6. Communicate and collaborate with cross-function OTC management staff7. Support and lead a continuous improvement environment8. Provide oversight for OTC RA processes and systems9. Hire, train and evaluate performance of direct reports10. Manage and prioritize OTC RA resources11. Manage projects as assigned by CSCA VP of RA or OTC business unit leader12. 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 VP13. Develop strategies and tactics to support first to market commercial opportunities and minimize time to product launch14. Mentor staff to maximize the leadership talent poolExperience Required1. 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 required2. Ability to monitor, analyze, raise awareness, and assess impact of regulatory issues for executive stakeholders inside and outside of Regulatory Affairs3. Advanced verbal and written presentation and communication skills are necessary4. Ability to utilize advanced business and financial acumen in decision making5. The ability to effectively lead cross-functional management-level teams is required6. Advanced knowledge of scientific, regulatory, and legal terminology is necessary7. 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 affairs8. 10 or more years of experience in direct supervision9. Advanced degree preferredExternal applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.We are an equal opportunity employer. All qualified applicants will receive consid