Global Regulatory Affairs - Associate Director

Global Regulatory Affairs - Associate Director

Global Regulatory Affairs - Associate DirectorTracking Code2009879Job Description
This position will provide strategic direction to the development of new products in support of Consumer Healthcare Products, Generic Prescription Drugs or Infant Formulas. 
Other responsibilities include:
* Collaborate with GSA Leadership, commercial teams to develop regulatory strategy, milestones and submission deliverables for development of new Consumer Healthcare, Generic Prescription Drug or Infant Formula products, supporting the company's first-to-market strategy.
* Collaborate with project teams, develop tactics supporting first to market commercial opportunities, minimize time to product launch.
* Hold face-to-face meetings, negotiate directly w/FDA, participate in industry trade groups to resolve regulatory issues, and/or prepare written responses from the department or company executives.
* Establish systems and foster a culture of continuous improvement.
* Recommend, provide leadership to specific and/or global process improvement initiatives enhancing the organization's support to new product introductions, global standardization, quality or regulatory strategy.
* Maintain regulatory operations in compliance GMP standards, laws and regulations.
* Coach, develop staff to advance and grow in the regulatory organization. Assign, balance workloads among teams/individuals balancing development and project support requirements.
* Establish, monitor performance metrics to drive "Best-in-Class"Required Skills
* Excellent analytical skills, ability to apply policies and general regulations to specific products or projects.
* Demonstrated leadership skills, ability to create and communicate strategies to the team and management. 
* Excellent verbal and written communication skills.
* The ability to work effectively on project teams. 
* Knowledge of scientific, regulatory and trade dress terminology. 
* Bachelor degree in health sciences field (biochemistry, chemistry, pharmacy or pharmacology). Advanced degree in life sciences preferred.Required Experience
* Minimum 10 years experience in health care/pharmaceutical industry, 6-8 years of progressively responsible experience in regulatory affairs.   
* Previous supervisory experience. Job LocationAllegan, MI USPosition TypeFull-Time/Regular
Position Physical Requirements
N/A