4 Senior Director Regulatory Affairs Jobs in Grand Rapids, MI
Perrigo Company plc is Hiring a Senior Director Regulatory Affairs Near Grand Rapids, MI
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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 Role
- Confirm that project plan due dates are consistent with regulatory strategy
- Work directly with Regulatory Agencies to resolve regulatory issues
- Direct and manage contacts with outside consultants to resolve regulatory issues
- Represent regulatory affairs in leadership meetings
- Ensure appropriate basis to marketing strategies are identified and/or implemented; Identify and employ advanced regulatory strategies
- Communicate and collaborate with cross-function OTC management staff
- Support and lead a continuous improvement environment
- Provide oversight for OTC RA processes and systems
- Hire, train and evaluate performance of direct reports
- Manage and prioritize OTC RA resources
- Manage projects as assigned by CSCA VP of RA or OTC business unit leader
- 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
- Develop strategies and tactics to support first to market commercial opportunities and minimize time to product launch
- Mentor staff to maximize the leadership talent pool
- 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
- Ability to monitor, analyze, raise awareness, and assess impact of regulatory issues for executive stakeholders inside and outside of Regulatory Affairs
- Advanced verbal and written presentation and communication skills are necessary
- Ability to utilize advanced business and financial acumen in decision making
- The ability to effectively lead cross-functional management-level teams is required
- Advanced knowledge of scientific, regulatory, and legal terminology is necessary
- 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
- 10 or more years of experience in direct supervision
- Advanced degree preferred
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. Our full Equal Employment Opportunity and Affirmative Action Policy Statement is available on our main career site in English and Spanish and will be provided in other accessible forms for persons with disabilities. #DIV
Job Summary
Full Time
$156k-207k (estimate)
06/10/2024
07/05/2024
The job skills required for Senior Director Regulatory Affairs include Regulatory Affairs, Leadership, Chemistry, Pharmaceutical Industry, Communication Skills, Decision Making, etc. Having related job skills and expertise will give you an advantage when applying to be a Senior Director Regulatory Affairs. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Senior Director Regulatory Affairs. Select any job title you are interested in and start to search job requirements.
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