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Regulatory Affairs Process and Business Operations

Location San Rafael, California


Regulatory Affairs

Regulatory Business Operations -Associate Director

The Associate Director is accountable for managing Regulatory business operations in alignment with the vision and strategy of Global Regulatory Affairs. Key areas of responsibility may include oversight and support related to:development and management of regulatoryprocesses; learning and development activities; new hire onboarding;compliance tracking and management; support on regulatory audits;document management practices; and technology/tool development to enhance or improve regulatory work processes.  This role may chair or represent Global RA on selected cross-functional working groups or related governance committees. The incumbent will manage within Regulatory Affairs learning and development activities; develop and manage written procedures, tools and other regulatory best practices; strategize the best available technologies to ensure Regulatory processes are efficient and effective worldwide; oversight of document management processes and systems and other related regulatory documentation activities.

The successful candidate must have good experience with Regulatory processes and activities, globally preferred, and a command of electronic document management processes and systems. Excellent communication skills and ability to work well with a diverse global department is a must.

The position reports to the Head of Regulatory Global Labeling and Regulatory Operations

Responsibilities will likely include the oversight of a range of Regulatory Affairs operational areas which may include, but are not limited to:

Learning & Development

The incumbent is responsible for Learning and Development including managing the design, development and delivery of training and education across BioMarin Global Regulatory Affairs.

S/he also drives the development of learning strategies to advance proficiency. This is a leadership management role with opportunity for strategic influence. The Associate Director is expected to assume a variety of additional leadership responsibilities, including leading process improvement and change management initiatives within Global Regulatory Affairs.

The individual in this position exhibits mastery of training development. S/he also demonstrates advanced skills related to problem solving, leadership, vendor management, and project management. 

  • Oversee the development and integration of Regulatory Affairs New Hire onboarding processes and procedures
  • Develop or conduct employee regulatory training.
  • Perform needs analysis, assessing base competencies and proficiency of organizations/functions in order to identify needs and address curriculum gaps, including:
  • Working with individual functions to determine needs and conduct assessments
  • Collaborate with global and regional colleagues to build an understanding of learning needs in the context of long term and near term strategic goals
  • Lead the design of effective course curriculum and workshops to meet organization needs, including:
  • Identify or source expert facilitators to deliver effective live training as required
  • Support trainers/facilitators in gathering or developing training content 
  • Obtain and or develop effective learning and development materials using a variety of media and blended approaches including coaching, classroom instruction, on-line learning, experiential learning, and self-guided learning 
  • Deliver trainings effectively, managing and responding to learner needs 
  • Lead evaluation activities to assess learning progress and ensure performance gaps are closed  
  • Use project management, change management, and learner engagement best practices to plan and conduct effective live training events 
  • Collaborate with Matrix Team and cross-functional colleagues to ensure that training needs are met in ways that are accurate, timely, and aligned
  • Lead the development of learning plans for all assigned compounds across the entire projected lifecycle of the compound 
  • Set annual learning priorities, communicate them and manage process for addressing ad hoc learning and development requests
  • Develop and maintain communications to ensure employees have knowledge of training requirements, events and resources
  • Keep abreast of trends and best practices in learning development and technology

Document Management

  • Oversee the Regulatory Affairs controlled documentation processes
  • Enhance Regulatory Affairs collaboration with the cross functional partners by educating partners in Regulatory Affairs processes and requirements and enlisting their support and advocacy for Regulatory Affairs document management.
  • Enhance the visibility of regulatory documents status for both internal and external stakeholders.
  • Support electronic document management initiatives impacting Regulatory Affairs.

Cross functional projects

Lead cross functional improvement projects, as appropriate

The Associate Director is expected to exhibit mastery-level competence in Regulatory Affairs core competencies, including communication and collaboration and adaptability and flexibility with advanced competence in leadership, strategy planning and problem solving. For example:

  • Articulates alignment between functional initiatives and corporate strategy such that employees, at all levels, fully understand their roles in achieving success
  • Actively models and encourages open, honest and clear communication across teams and functions
  • Holds team or function accountable for goal achievement by creating a shared sense of ownership for success
  • Identifies internal and external best practices, trends, developments or alternative approaches that can be leveraged for strategy development
  • Understands the scope of the problem and/or solution, as well as the span of control for the individual / team and advises appropriate course of action
  • Recognizes cross-functional, company-wide, or vendor-based impact of issues and opportunities and appropriately considers input and implications in solution development

Technology Management

  • Serve as Subject Matter Expert for Regulatory Affairs processes supported by technology
  • RepresentRegulatory Affairs in technology governance forums and partner with Regulatory Information Management Lead; address new tech requests and changes to existing systems
  • Liaise with internal stakeholders and IT, on behalf of Regulatory Affairs, to prioritize, communicate, and continually manage new technology projects, or changes to existing systems; represent Regulatory Affairs on the key internal technology decision making forums
  • Build Regulatory Affairs collaboration with business stakeholders and IT
  • Educate internal business partners and coop their support and advocacy of Regulatory Affairs technology planning and governance
  • Working with IT to assess budget and resources; planning out budget; Identify systems we want to implement and facilitate the approval process
  • Participate in capturing system business requirements and testing of Regulatory Affairs technology projects
  • Manage vendors and contractors as applicable to systems and technology project(s)
  • Elevate the utilization of the internal website as a resource for Regulatory Affairs

Provides “on-the-job” training to junior staff in improving leverage of technology and productivity applications

People Management

The Associate Director may manage contractors. Direct reports are not identified for this role at this time.

Education/Experience

  • BA/BS or higher in life or health sciences preferred.  Certificates or other education in regulatory compliance or contact management preferred
  • At least 8 years of relevant experience in Regulatory Affairs or related fields including strong electronic document management system experience
  • 4 years line management experience preferred
  • Experience in project management and learning and development a plus
  • Excellent oral and written communication skills
  • Exhibits a good understanding of general quality assurance concepts and regulatory best practices
  • Highly organized with a strong attention to detail
  • Successful history of solving problems of high complexity
  • Proven ability to manage both day-to-day operations, as well as project work in a fast-paced environment
  • Possess strong computer and Internet skills, including online document management experience
  • Expert in Microsoft Office (Outlook, Excel, Word, & PowerPoint)

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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