Associate Director, Regulatory Affairs
Novartis Pharmaceuticals Corporation
San Carlos, CA
Areas of Expertise Desired:
Directs the regulatory activities that support site and company projects and programs. Coordinate and supervise the development of regulatory strategies for new or modified pharmaceutical products, medical devices and medical device/pharmaceutical combination products under development or license for assigned projects. Provides regulatory guidance and leadership to USSC and partner-sponsored project/program teams. Manages internal staff and external resources to ensure quality and timeliness of submissions. Coordinates, prepares, edits and submits applications to regulatory authorities. Serves as principal regulatory contact with corporate partner programs and for Novartis at partnered meetings with regulatory agencies; primary regulatory representative to US and ex-US regulatory agencies for routine interactions. May select, develop, and evaluate personnel to ensure the efficient operation of the function.
Act as a combination product and medical device expert and contact for identified TAs and for the Department, and external line units in a specific area of expertise. Within the area of expertise and beyond, promote awareness within Novartis of worldwide legislation/guidelines, ensure proactive participation of the company in opportunities to comment on draft legislation/guidelines, promote best practices and provide training to Reg CMC, DRA, Development and ESO/TechOps.
Ensure, consistency of regulatory strategies and documentation and strong Reg CMC participation in interdepartmental meetings, in cooperation with Management team and group heads. Advise Reg CMC and line functions by taking into consideration regulatory issues, trends and processes for medical devices and combination products.
• Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives as well as an understanding of the business.
• Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.
• Establishes and assures adherence to budgets, schedules, work plans and performance requirements.
• Responsible for coordinating the preparation of drafts, edits, review and submission of regulatory dossiers in support of investigational and new device and/or drug applications, and post-approval submissions, for US and ROW (e.g., 510(K), IDE, IND, NDA, CTD, CTA, IMPD, MAA, Drug/ Device Master Files, Technical Files, Annual Reports, Amendments, Supplements, and etc.).
• Works with project teams and department management to develop regulatory strategies, identify regulatory risks, and enable earliest possible approval.
• Ensures that submissions meet format and content requirements applicable to specific health authority regulatory requirements (i.e., US, ICH, and ROW, ISO, IEEE, ASTM, etc.).
• Provides input on, and reviews specifications, methods, SOPs, protocols, reports, labeling, and etc. for regulatory compliance.
• Supports design control for project teams in the Regulatory role.
• Provides direction and requirements to internal staff to ensure high quality output and timely project completion.
• Ensures that documentation for all projects is maintained and kept current.
• Identifies Regulatory Affairs' SOP needs and discusses with site head/department.
• Drafts and reviews local Regulatory Affairs' SOPs and global medical device/combination product SOPs.
• Participates in, and provides regulatory guidance, strategy and leadership to working teams (both internal and partnered programs), Project Teams (Core), and Company Management.
• Serves as principle regulatory contact with corporate partner programs, and contract manufacturers.
• Develops and maintains timelines for department initiatives and corporate goals.
• Manages timelines for regulatory submissions.
• Functions as primary contact for project related interactions with US and Ex-US regulatory agencies for partner and internal programs.
• Solves problems of significant levels of complexity following established company policies and procedures; informs management of impacts.
• Works independently to complete assigned projects; keeps management informed on progress.
• Negotiates, interacts and supervises the activities of contract organizations and consultants in the preparation of regulatory submissions as necessary.
• Advises department, project teams and company on issues related to regulatory strategy; identifies areas of concern in regards to developing regulations.
• Provides input on Regulatory Affairs department activities, including but not limited to; staffing requirements, budget proposal and tracking, regulatory SOPs, training requirements, documentation retention policy and implementation, and etc.
• May be responsible for conducting performance reviews, and providing feedback and coaching to direct reports.
• Single point of contact for USSC regarding dissemination of new regulations and guidelines.
• Responsible for driving consistent and creative regulatory strategies and for sharing with management and others within Reg CMC, within matrix responsibility (TA, or other topic of expertise) and beyond.
• Within area of expertise, provide training, coaching and advise to Reg CMC and other line functions and promote awareness of worldwide medical device & combination products legislation/guidelines.
• Within area of expertise, ensure proactive participation of the company in opportunities to comment draft legislation/guidelines.
• Facilitate consistency in regulatory strategies and documentation by critically reviewing CMC documentation, coaching, participating in Reg CMC challenge meetings and integrating regulatory trends and experiences.
• Lead or participate in multidisciplinary teams focusing on continuous improvement and management initiatives.
• Represent Reg CMC in interdepartmental meetings, working groups and initiatives.
• Represent Reg CMC in Due Diligence and Divestment Teams.
• Increase awareness of Reg CMC contributions to other line units by educating them in the critical points of CMC strategies and documentation and by providing training/guidance.
• Hold Lessons Learned sessions within and external to Reg CMC leading to improved strategies and decisions on common regulatory approaches. Ensure information is archived and available.
• Represent Reg CMC aspects within TRD-EP, TRD-LP, CPIC meetings etc.
• Act as a senior member of the section or department with a function or specific skill set supporting the Group, Section or Department Head, as appropriate; assist Group Head/Section Head in coaching and training other associates within department as necessary
• For projects/products under responsibility, proactively communicate regulatory strategy, key issues and any other critical topics throughout life cycle in an adequate and timely manner to the project team and to appropriate management level in TechOps, DRA and TRD as appropriate. Provide strategic regulatory guidance, advice and training to line units within Development and TechOps.
• Lead cross-functional Health Authority Response Teams (HARTs) for assigned development projects and/or marketed products, as appropriate.
• Lead preparation of CMC dossier risk analyses, contingency plans and Lessons Learned documentation on major submissions under own responsibility.
• Ensures compliance with GMP/HSE regulations, Novartis policies, procedures and standards as appropriate for the role. Champions a Quality Culture and ensures a safe working environment.
• A minimum of a Bachelors degree in a scientific discipline is required. An advanced degree is preferred. Equivalent experience may be accepted.
• A minimum of 10 years experience in the pharmaceutical or other related industry is required.
• Minimum of 7 years hands-on Regulatory Affairs experience in the pharmaceutical industry dealing with combination products and/or medical devices.
• Experience in the respiratory therapeutic area a plus.
• Strong verbal and written communication skills are required, as well as presentation skills; must be able to present departmental policies and practices.
• Must be detail- and goal-oriented, quality conscientious, and customer-focused.
• Must be able to adhere to strict project timelines, and to advise teams and management of impacts and changes in project timelines.
• Experience working in a multi-disciplinary team environment is required.
• Ability to manage changing priorities multiple tasks, and to communicate impact to project teams is required.
• Strong computer skills in Word, Excel, PowerPoint and Adobe Acrobat, and working knowledge of electronic publishing/file management systems are an asset; can use Internet for research applications.
• Must possess an understanding of cGXP regulations and provide guidance to project teams on regulatory compliance issues.
• Knowledge/experience of worldwide regulations, guidelines and regulatory processes for NCEs and product life cycle maintenance.
• A good understanding of chemistry, analytics and pharmaceutical technology and in-depth understanding of the drug development process.
• Proven track record of early recognition of potential Regulatory CMC issues, distilling complex situations, sound risk assessment and overcoming hurdles.
• Ability to work in cross-functional and international environment.
• Strong team player.
• Proven track record of strategic thinking maintaining awareness of business impact.
• Proven track record of successful risk assessment.
• Respected subject matter expert within department and external line functions.
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