Responsible for oversight of all regulatory activities of regulatory team. Develops strategies for earliest possible approvals of drug applications and device registrations. Ensures appropriate project/ program Regulatory support. Provides counsel to and manages regulatory team. Participates in higher level interactions with external partners. Formulates corporate responses to regulatory agencies and pharmaceutical group initiatives. Review of regulatory submissions and responses. Functions as primary senior regulatory representative for negotiations with US and ex-US regulatory agencies. Interacts with senior level regulatory personnel at partner companies and contract manufacturers. May select, develop, and evaluate personnel to ensure the efficient operation of the function.
Participates with other senior managers to establish strategic plans and objectives. Makes final decisions on administrative or operational matters and ensures operations' effective achievement of objectives. Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures budgets and schedules meet corporate requirements. Coordinates and ensures internal/external resources are appropriate to ensure quality and timeliness of global regulatory submissions. Assists in the selection and early development of programs by developing regulatory strategies and identifying regulatory risks. Reviews regulatory submissions and responses. Provides guidance, resources and timeline targets to internal staff to ensure project completion. Responsible for ensuring Regulatory Affairs has resources (staffing and facilities) to maintain documentation. Ensures SOPs are adequate to address needs and compliance. Ensures internal and/or external resources are adequate to provide Regulatory Affairs support for company projects. Interacts with (senior level) regulatory personnel at partner companies, contract manufacturers and regulatory agencies. Ensures resources are identified to support short- and long-term corporate goals, and communicate impacts to Project Management/Managers and senior management. Functions as primary senior contact for negotiations and interactions with US and ex-US regulatory agencies for internal programs. Interacts with internal and external executive management requiring skillful negotiations of complex matters to influence policy making bodies. Evaluates industry organizations and governmental agency initiatives and prepares company responses. Resolves significant conflicts and disputes within and/or across departments. Negotiates win/win scenarios for organizational productivity and efficiency. Reviews and manages regulatory departmental activities, ensuring alignment with company project timelines. Manages departmental budget to plan, communicating major deviations and impacts to senior management. Negotiates, interacts and supervises the activities of contract organizations and consultants in the preparation of regulatory submissions as necessary, balancing internal and external resources. Advises department, project teams and company on issues related to overall regulatory strategy; identifies and communicates areas of concern in regards to developing regulations. Provides input to R&D department activities, including but not limited to; Regulatory Affairs staffing requirements, budget proposal and tracking, regulatory SOPs, training requirements, documentation retention policy and implementation, and etc. Provides regulatory opinion, reflecting Regulatory Affairs department practice/philosophy/policy to executive management. May be responsible for conducting performance reviews, and providing feedback and coaching to direct reports.
A minimum of a Bachelors degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 13 years pharmaceutical or other related industry is required. A minimum of 10 years hands-on Regulatory Affairs experience and knowledge of pharmaceutical and general medical device regulations and guidances is required. Experience with multiple regulatory disciplines (i.e., CMC, preclinical, clinical, labeling, etc.) is preferred. A minimum of 10 years previous management experience may be required. Excellent written and verbal interpersonal skills required; these must be effectively used to influence many diverse internal and external customer groups. Must be experienced in staff and organizational development and problem solving, career and development planning, identifying training needs, and proactive resolution planning. Must be detail- and goal-oriented. Must be able to adhere to strict project timelines and budgets, and to advise teams and management of impacts and changes in project time-lines. Ability to forecast timelines, resources and budgets, and resolve bottlenecks is preferred. Experience working on, leading and influencing multi-disciplinary teams is required. Ability to manage changing departmental priorities, evaluate and assign resources, and communicate timeline and resource impacts to project teams and management is required. Working knowledge of electronic publishing/file management systems are an asset. Ability to guide and influence the organization appropriately on cGXP is required.