Bausch + Lomb Jobshttp://bausch.jobs2012-05-23 10:48:47.867991USAAliso Viejo SiteTitle: Global Regulatory Affairs, Manager Location: United States-California-Aliso Viejo Site The Surgical Regulatory Affairs Manager handles all regulatory development aspects for surgical devices as assigned. These include IOLs, Inserters and Solutions. The incumbent participates on the product development team to provide regulatory guidance for surgical devices assigned. They also manage relevant regulatory strategy components and interactions with Regulatory Authorities for their assigned surgical products and may perform due diligence efforts on new product opportunities. ESSENTIAL DUTIES AND RESPONSIBILITIES: Responsible for developing a global product regulatory strategy for surgical devices Responsible for obtaining and maintaining all US and EU approvals Responsible for developing and maintaining EU Tech Files and ROW Master Files Liaise with global regulatory counterparts to ensure regional requirements are incorporated into product strategy development Develop a product regulatory timeline aligned to Bausch & Lomb’s product development, with key regulatory milestone, and activities for agency filing Coordinate with the team on the development of product labels Ensure labeling content and product documentation is developed in accordance with regulatory requirements Participate as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions Coordinate with RA Global Expansion team to ensure timely and accurate submissions to Regulatory Authorities Act as a regulatory contact for assigned country Regulatory Authorities for surgical devices Manage interactions with other Bausch & Lomb functions (e.g., Quality, Compliance) during Regulatory Authority inspections Provide regulatory guidance/input to surgical device change control and internal product review boards TECHNICAL COMPETENCIES: Knowledge of surgical device regulatory affairs discipline throughout the product lifecycle, including Design, Development, Promotion and Advertising, Labeling, Change Control, Commercialization, and Operations Knowledge of domestic and international laws, regulations, and guidance that affect assigned devices Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for assigned devices Ability to influence and partner with cross-functional teams in a global surgical organization Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks. PROFESSIONAL COMPETENCIES: Demonstrated ability in analytical reasoning and critical thinking skills Strong capability to contribute and lead a 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 influence operational excellence and performance metrics Risk adverse where needed with the ability to identify potential solutions to complex problems Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. Bausch Lomb is an equal opportunity employer. 8 years relevant medical device industry and regulatory experience Ophthalmic Surgical device regulatory experience highly preferred Bachelors degree in science or health related field preferred Advanced degree preferred (PhD, MD, MS, PharmD, or equivalent) Job: Regulatory Affairs2012-05-10 20:29:31United StatesBausch + LombCalifornia00007684CAAliso Viejo Site, CA28612454http://bausch.jobs/xml/28612454/jobUSAAliso Viejo SiteTitle: Regulatory Affairs Intern Location: United States-California-Aliso Viejo Site Bausch & Lomb Surgical develops, manufactures and distributes ophthalmic surgical devices for the U.S. and international markets. This position requires the incumbent to work under the direct supervision of senior regulatory professionals in the collection and collation of materials required for various country submissions. Additional duties include: • Support preparation of data packages • Coordinate global regulatory assessments • Organize archived documentation • Track and communicate international approvals data • Produce draft documents for registration renewals tofacilitate the maintenance of product approvals. • Excellent writing and verbal communication skills • Some working knowledge of global device regulations • Strong problem-solving and analytical ability • Required computer skills include Microsoft Word and Microsoft Excel. • Comfortable working in a variety of corporate business management computer systems. • Background in a technical or scientific discipline such as biology, chemistry, physiology, engineering, medical or law. Job: Regulatory Affairs2012-05-07 18:35:37United StatesBausch + LombCalifornia00007699CAAliso Viejo Site, CA28481698http://bausch.jobs/xml/28481698/jobUSAAliso Viejo SiteTitle: Surgical Global Regulatory Affairs Director Location: United States-California-Aliso Viejo Site The Global Regulatory Affairs Director manages all regulatory aspects of Bausch & Lomb’s Surgical products throughout their lifecycle. The position covers Equipment, Instruments and Accessories, IOLs, Inserters and Surgical Solutions. The incumbent is responsible for the overarching global surgical regulatory strategy, and managing interactions with various regulatory authorities. Provides directional guidance to the business on how to prepare products for approval and keeps abreast of evolving global regulatory requirements. Leads Regulatory Affairs personnel associated with the Surgical product lifecycle (which includes but is not limited to Regulatory Product Development, Advertising and Promotion, Labeling, and evaluation of changes to product, process, facilities, etc.). Leads and develops personnel to promote compliance with all laws, regulations, or guidance. The position is responsible for regulatory activities related to design, development and US/EU approval. Specific Job Duties : Serve as a leadership team member for Bausch & Lomb’s Surgical Regulatory Affairs function Oversee the development of global product regulatory strategies for all Bausch & Lomb Surgical products Oversee the regulatory functions in relation to device design & development and product approvals, consistent with Bausch & Lomb agreed upon timelines Manage interactions with Regulatory Authorities for Surgical products Build relationships with regional and global Bausch & Lomb Regulatory Affairs teams Provide regulatory support to other Bausch & Lomb functions (e.g., Quality, Compliance) during Regulatory Authority inspections Provide regulatory guidance/input to internal product review boards 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 Education & Experience Bachelors degree in science or health related field Advanced degree highly preferred (PhD, MD, MS, JD, or equivalent) 10 years medical device industry and regulatory experience Ophthalmic Surgical device regulatory experience highly preferred Qualifications Strong capability to lead and support a collaborative team environment Demonstrated ability in analytical reasoning and critical thinking skills Ability to manage in a highly matrix organization Demonstrated ability to lead a multidisciplinary team 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 influence operational excellence and performance metrics Risk adverse where needed with the ability to identify potential solutions to complex problems Technical Qualifications Knowledge of ophthalmic surgical device regulatory affairs discipline throughout the product lifecycle, including Design, Development, Promotion and Advertising, Labeling, Change Control, Commercialization, and Operations Knowledge of domestic and international laws, regulations, and guidance Knowledge of clinical development, including responsibilities for successful management of development milestones and global market authorization Ability to influence and partner within Bausch & Lomb Global Regulatory Affairs group and with cross-functional teams Ability to take innovative ideas and design a successful product regulatory strategy and, in so doing, increase probability of regulatory approval Ability to support the product development team to assess whether technical arguments are presented clearly and conclusions are adequately supported by data Managerial Responsibility 4 Job: Regulatory Affairs2011-12-14 01:15:57United StatesBausch + LombCalifornia00007395CAAliso Viejo Site, CA25342740http://bausch.jobs/xml/25342740/jobUSAMadison SiteTitle: Senior Director Regulatory Affairs Location: United States-New Jersey-Madison Site The major objective for this position is set the strategic direction for Regulatory activities affecting the geo-expansion. This includes but is not limited to overseeing the development of all regulatory strategies, preparation of regulatory applications, labeling, advertising and promotional review, and life cycle management for the pharmaceutical division. The primary goal of this project is to meet the deadlines and yearly goals for regulatory submissions as established for the pharmaceutical division. It is expected that the targeted yearly submission numbers are met and/or exceeded. A critical subtask is to oversee health authority liaison activities for all global geo-expansion submissions. Work with the local regulatory representatives to ensure proper activities with the appropriate regulatory agencies. The primary team role for the Dir, Regulatory Affairs Geo Expansion is to act as the face for the geo-expansion team for internal and external stakeholders. You will set the regulatory direction by proactively developing new and innovative approaches for pursuing business objectives within regulatory frameworks. The Dir, Regulatory Affairs Geo Expansion will work closely with a diverse, cross-functional team consisting of clinical operations, biostatistics, pharmacovigilance and safety. As part of this team effort, the person will actively be involved in multiple projects and provide constant leadership and direction throughout the whole process. This is your chance to expand your growth opportunities by providing leadership to a company initiative that will have a very strong impact on the pharmaceutical business unit. This role while very hands on will be instrumental in the development and evolution of this Regulatory group. Part of your development in this role will involve providing continuous strategic insight for the projects for both in licensing and existing products. Specific Job Duties: · Sets the regulatory direction by proactively developing new and innovative approavhes for pursuing business objectives within regulatory framework. · Lead regulatory geo-expansion staff on a global level and ensure close collaboration with the regional regulatory representatives throughout the world. · Set direction and strategy for global health authority meetings regarding Bausch Lomb Pharmaceutical products · Candidates must be recognized as a regulatory expert internally and externally with in-depth knowledge of the global regulatory environment affecting the industry with a proven track record of taking products through to completion. · They must also have solid business acumen with the ability to work effectively across diverse functions and levels within the company and understand the key interdependencies required to develop and market pharmaceutical products on a global level. · Must have 15 years of global regulatory affairs experience. Experience with Ophthalmics is a plus. · Advanced degree preferred (Ph.D, MBA, PharmD, JD, MD) Managerial Responsibility: There are currently 11 contractors globally that this person will be managing directly. Job: Regulatory Affairs2011-09-27 21:25:06United StatesBausch + LombNew Jersey00007255NJMadison Site, NJ23876967http://bausch.jobs/xml/23876967/job