This position is responsible for leading the regulatory activities providing management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals. Regulatory activities include but are not limited to communications with all regulatory agencies and assist as a liaison between the R&D, Quality, Operations, and commercial groups, ensuring adherence to the objectives and timelines of the R&D and Commercial annual plans.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
Develop, maintain and communicate the RA strategy to support New Product and Life-Cycle Management processes in conjunction with the Regulatory Affairs Team. (i.e., regulatory strategy, compliance strategy, etc.)
Responsible to ensure department is aligned and appropriately structured to support achievement of the annual plan.
Leads key R&D regulatory and business objectives and ensures implementation.
Responsible for the recruitment, training, coaching and performance management of associates, creating and promoting an environment of teamwork and empowerment. Ensure the department is staffed with appropriately qualified personnel. Ensures the development of the required competencies of team members for their role and future progression.
Develops and manages relationships with external regulatory agencies, industry groups and business partners. Acts as key corporate regulatory contact.
Develops and maintains relationship with internal business partners and key stakeholders to ensure business objectives are met.
Educates and informs the organization on industry and regulatory trends and the potential business impacts.
Serve as the source for regulatory information and guidance for all business units. Plan and manage the local regulatory activities.
Review, evaluate, analyze and recommend actions on all regulatory issues pertaining to product approvals and launch.
Liaises with Sales and Marketing, Business Development and R&D to provide regulatory strategies during new product planning.
Maintain up-to-date knowledge on regulatory requirements to assure compliance with current regulations.
1. Successful mapping of Regulatory pathways for active projects
2. Agency approval of submissions single cycle
3. Effective budget analysis and execution
4. Employee development and engagement
EDUCATION/CERTIFICATION: A minimum of a BA/BS within a scientific discipline is required. Advanced/ terminal such as Master, or PharmD is a plus.
REQUIRED KNOWLEDGE: Proficiency in electronic submissions/ electronic filing systems, Microsoft Office/ Lync, SharePoint required.
REQUIRED: 15-plus of applicable in the global regulatory affairs environment and at least 10 of management leading professionals. A strong background in pharmaceutical and medical device product approvals is a must.
SKILLS/ABILITIES: Expertise to strategize, execute, develop and improve regulatory systems for compliance and efficiency
Ability to react calmly, thoroughly and quickly in urgent situations.
Leadership that is inspirational and collaborative
Ability to address new product initiatives outside of companys core product and process technology domain.
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