Regulatory Affairs Associate Director - Support ServicesPosted: November 15, 2009
Position Summary The Global Regulatory Affairs Support Services Associate Director provides leadership and direction for Pharmaceutical Regulatory • Operations? centers of excellence. Coordinates with other Bausch & Lomb regulatory functions to streamline regulatory operations and create a more effective regulatory operation. Specific Job Duties ? Serve as a leadership team member for Bausch & Lombs Pharmaceutical Regulatory Affairs function ? Manage the overall operations of Pharmaceutical Regulatory Affairs, which is defined as the submissions, publishing, technology, training, and document management functions ? Identify opportunities to streamline and centralize Pharmaceutical Regulatory Affairs to promote operational excellence ? Monitor internal and external influences to regulatory operations, and coordinate with impacted teams to modify existing standards, policies, and procedures ? Provide guidance and oversight to global submissions and product registrations for Bausch & Lomb Policy and Regulatory Authority requirements ? Provide guidance and oversight into Regulatory Affairs outsourcing strategy and vendor relationships ? Provide direction and monitor compliance of mandated regulatory training to maintain compliance with Bausch & Lomb policies ? Provide oversight and monitor the Global Regulatory Standards Framework that defines who owns, maintains, and drives implementation of SOPS and work instructions ? Provide monthly operations reports on key performance indicators and vendor performance to create transparency of Regulatory Affairs effectiveness ? Select, develop, and motivate a regulatory team that supports personal growth and a culture of compliance ? Play a significant role in the performance management process and career development programs for supervised regulatory personnel Technical Competencies ? Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle including Development, Commercialization, and Operations ? Knowledge of current and emerging issues and trends in the regulatory environment ? Knowledge of industry systems, tools, and technology that support an efficient and compliant regulatory organization ? Ability to identify training program curriculum that supports development and maintenance of skills for regulatory personnel ? Ability to apply regulatory knowledge to improve regulatory operations ? Capability to react quickly to changes in the regulatory environment and make decisions to minimize risk to the business ? Ability to influence and partner within regulatory and with cross-functional teams in a matrix global pharmaceutical organization ? Ability to assess project risks and where appropriate, recommend contingency plans and strategies to mitigate risks ? Ability to negotiate vendor contracts and establish service level agreements (SLAs) for regulatory affairs service providers Professional Competencies ? Demonstrated ability in analytical reasoning and critical thinking skills ? Strong capability to contribute lead and support a collaborative team environment ? Strong business acumen and ability to see the business drivers outside of Regulatory Affairs ? Excellent communication skills; both oral and written ? Strong interpersonal skills with the ability to influence others in a positive and effective manner ? Demonstrated ability to contribute to a continuous learning and process improvement environment ? Capacity to react quickly and decisively in unexpected situations ? Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies ? Focused ability to operational excellence and performance metrics ? Risk adverse where needed with the ability to identify potential solutions to complex problems Please refer to job code 750392 when responding to this ad.
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