Date Posted:

10/21/2008

 

Job ID:

1661

 

Company:

We are an eye care company. We are committed to making vision perfect and improving the lives of consumers around the world. We offer the world’s most complete collection of eye care products. Our healthcare brand is one of the best known and most valued worldwide. Our products are available in more than 100 countries. We continue to invent new materials, engineer new technologies, and create ground-breaking ways to help people see better.

 

Location:

Florida - West Coast

 

Reports To:

VP Regulatory Affairs

 

Salary:

78-100K Bonus 15%

 

Education:

BS/BA degree in technical or scientific discipline required. Advanced degree or additional professional training preferred.

 

Requirements:

7 years experience in Regulatory Affairs (Pharma). Experience in preparing medical device submissions and food supplements a plus. Project management experience or similar experience within R&D preferred. Must have excellent communication, organization and writing skills. Strong influencing and negotiation skills. Commercial knowledge and understanding of business needs. Computer literate (MS) and internet use. Special Skills: Must be familiar with existing legislation and keep up-to-date on development and trends affecting product registration worldwide. Specialized Training: Must be fluent in Spanish language.

 

Duties:

Responsible for Regulatory activities in Latin America. Communicate with the Commercial team, Global Strategy, and local country managers. Work with the Global Regulatory Affairs group to develop work schedules to best meet regional and global demands. Act as the liaison with relevant internal departments and licensing authorities to drive projects to successful conclusion and to meet company-agreed goals. Work closely with Company affiliates (Germany, France, UK, Canada) to coordinate projects. Provide timely resolution to issues raised by national health authorities. Respond to general regulatory queries. Ensure key personnel at our organization are kept informed of developments in a timely manner.

 

Date Posted:

10/21/2008

 

Job ID:

1659

 

Company:

We are an eye care company. We are committed to making vision perfect and improving the lives of consumers around the world. We offer the world’s most complete collection of eye care products. Our healthcare brand is one of the best known and most valued worldwide. Our products are available in more than 100 countries. We continue to invent new materials, engineer new technologies, and create ground-breaking ways to help people see better.

 

Location:

Upstate New York

 

Reports To:

VP Regulatory Affairs

 

Salary:

78-100K Bonus 15%

 

Education:

BA/BS degree in a technical or scientific discipline. Advanced degree or additional professional training would be of value.

 

Requirements:

5-7 years experience in Regulatory Affairs with a demonstrated capability and experience preparing submissions for US Class II/Class III medical devices, as well as non-US medical device products. 10+ years experience in the medical device or drug industry desired. Knowledge of medical device or drug GMPs desired. Special Skills: Must have excellent communication, organization, and writing skills. Specialized Training: Computer literate with general office software and internet use.

 

Duties:

Provide Regulatory Affairs support to manage product development projects to include 510(k), PMA, IDE, label/advertising review and other Regulatory Affairs support activities. Prepare US and non-US product submissions such as 510(k), PMA, IDE, CE technical file. This requires participation in product development teams as well as to review, analyze and comment on technical reports. Review, approve, and provide guidance for labeling and advertising of B&L device products. Counsel technical and business groups to establish direction, based on available data and regulatory considerations. Provide review and guidance of failure Investigations and corrective actions referred to Regulatory Affairs. Provide guidance on Regulatory compliance. Review and approve policies and procedures. Interact with US and non-US government officials on product approval and compliance issues. Provide input and comment to regulations and standards which may affect our device products.

 

Date Posted:

10/7/2008

 

Job ID:

1653

 

Company:

We are a privately held technology driven company. We lead the way in the development and commercialization of a conservational and renewable transportation fuel. We also provide custom-made enzymes for use within the health and nutrition markets.

 

Location:

Southern CA

 

Reports To:

Director Regulatory

 

Salary:

110-130K

 

Education:

B.S. or M.S. in Biology or related field.

 

Requirements:

5+ years experience in Regulatory Affairs with preferably some prior experience in the biotech industry. Familiarity with the food industry/ chem. industry and with biotech as opposed to pharma industry and biotech.

 

Duties:

Sr Manager, Regulatory will assume a leadership role in the development of regulatory submissions for company products across business units. Develop Regulatory strategy and timelines to assure high-quality and on-time regulatory submissions. Participate on Product Development teams. Interact with and provide regulatory support to QA/QC, Manufacturing, Process Development, Business Development and Product Managers. Maintain Document Control system for pertinent regulatory documents. Knowledge of FDA food regulations, food cGMPs, EPA TSCA regulations, and NIH Guidelines is desirable.

 

Date Posted:

3/17/2008

 

Job ID:

1609

 

Company:

We are a specialty pharmaceutical company committed to developing new techniques to help physicians individualize patient care. We focus on the treatment, diagnosis and detection of gastrointestinal, autoimmune and inflammatory diseases and disorders. Company's' strategy includes the marketing and delivery of pharmaceutical products balanced by its proprietary, top notch diagnostic testing services. By integrating therapeutics and diagnostic services, company addresses the continuum of patient care, thus afford physicians with a across-the-board solution to treat chronic diseases.

 

Location:

Southern CA

 

Reports To:

VP Regulatory

 

Salary:

115-140K

 

Education:

PhD or MS in Chemistry, or 8 years of experience and strong working knowledge of CMC.

 

Requirements:

5-10 years of pharmaceutical experience in an industry setting in the area of Chemistry, Manufacturing and Controls (CMC) in a regulatory capacity. Experience preparing CMC supplements for approved NDAs as well as preparing CMC sections in NDAs BLAs PMAs, 510k’s and INDs. Successful track record of approvals and success in negotiating the most expeditious approval times. Experience with all phases of clinical development and a thorough understanding of the differing CMC requirements thereof. Must have strong familiarity with cGMP requirements, all guidance documents and federal regulations related to CMC requirements. Also, must have strong leadership and collaboration skills.

 

Duties:

Associate Director of Regulatory Affairs will manage all aspects of CMC regulatory dossiers in support of manufacturing, chemistry or controls changes to marketed products. Key responsibilities include but are not limited to: Provide CMC regulatory affairs strategy to ensure most expeditious approval pathway for manufacturing changes, such as new suppliers of ingredients or manufacturing site changes to marketed products. Planning, writing, and coordinating the preparation of the CMC regulatory dossiers in a cross-functional team setting according to strict timelines and with attention to optimal quality. Providing CMC regulatory expertise to the Manufacturing group and all cross-functional project teams with regard to CMC regulations pertaining to development of pharmaceutical drug products for U.S. registration. Advise on additional CMC requirements for transitioning from Phase 2 to Phase 3 compounds and ultimate commercialization. Preparation of Annual Reports for the NDAs of marketed products. Leading the planning, coordinating and executing of essential milestone meetings such as End of Phase 2 and teleconferences with FDA CDER & CDRH on CMC related topics. Writing CMC conformance guides for all of our marketed products, including expiration dating, approved manufacturing processes and suppliers of ingredients, container closure systems and stability programs. Authoring and approving SOPs related to CMC topics and change control documents as necessary.