better Legal Job at Biotechnology Pharmaceuticals

Business Title Compliance Associate - QA Requisition ID 19372BR Job Category Biotechnology/Pharmaceutical Locations USA - Nationwide Shift 1 Job Posting Covance is expanding its biotechnology services business to the United States. This is an exciting opportunity to get in on the ground floor of a rapidly growing scientific service offering with one of the world's premier drug development companies. The biotechnology business unit will provide a comprehensive portfolio of contract GLP and GMP laboratory services

Business Title Senior Associate Regulatory Submissions Requisition ID 19157BR Job Category Regulatory Affairs Locations Peru Shift 1 Job Posting Responsible for the timely preparation of submissions (IND/CTA and others) or of parts thereof to Regulatory Authorities, working to a high standard with minimal supervision. Interacts with Regulatory Authorities and with clients to support regulatory activities. Proactively interacts with other Covance groups and with clients to provide guidance regarding Regulatory

Business Title Senior Associate Regulatory Submissions Requisition ID 19156BR Job Category Regulatory Affairs Locations Brazil Shift 1 Job Posting Job Summary: Responsible for the timely preparation of submissions (IND/CTA and others) or of parts thereof to Regulatory Authorities, working to a high standard with minimal supervision. Interacts with Regulatory Authorities and with clients to support regulatory activities. Proactively interacts with other Covance groups and with clients to provide guidance regarding

Business Title Senior Associate Regulatory Submissions Requisition ID 19155BR Job Category Regulatory Affairs Locations Chile Shift 1 Job Posting Job Summary: Responsible for the timely preparation of submissions (IND/CTA and others) or of parts thereof to Regulatory Authorities, working to a high standard with minimal supervision. Interacts with Regulatory Authorities and with clients to support regulatory activities. Proactively interacts with other Covance groups and with clients to provide guidance regarding

Business Title QA / Regulatory Specialist Requisition ID 16877BR Job Category Quality Locations UK - Maidenhead Shift 1 Job Posting Covance have exciting opportunities for Quality Assurance Personnel with relevant experience in the field of Clinical / Regulatory GCP auditing to join their expanding Global Quality Assurance and Compliance team. The successful candidates will be active team players and provide a variety of QA services to clients both internally and externally. The candidates should be pragmatic

Description Job Summary As we approach the commercialization phase of our first product, DX-88, a novel therapeutic for the treatment of Hereditary Angioedema, Dyax isadding new skill sets toourDevelopmentteamsto meet this exciting new stage of evolution in the organization. The Senior Regulatory Affairs Specialistwill participate to regulatory submission strategy, planning and implementation for Dyax products worldwide. This role will play a key function within the regulatory group and work on both commercial

About Novartis Institute of Biomedical Research: At Novartis Institutes for BioMedical Research (NIBR), the global research organization of Novartis, we are committed to discovering innovative medicines to cure disease and improve human health. By hiring the best academic, biotech, and pharmaceutical trained scientists, we have fostered an atmosphere for drug discovery where innovation is rewarded. It is ultimately the talent of the individual that determines our success, while our state-of-the-art technologies

to fill a new position in its Legal Regulatory Compliance Department FDA practice group which...experience with at least 4 years providing legal counsel in food and drug laws...at least 5 7 years of applicable legal experience from law firm corporation and or...

Counsel in our fast paced in house legal department...skills and at least 5 years corporate legal experience including corporate law corporate minutes securities...SUMMARY Seeking a Legal Secretary with strong organizational skills and at...

Description: Provide advice and counsel to the Consumer Business Unit. Counsel commercial, research and manufacturing functions. Support litigation matters, acquisitions, licenses and alliances. Support industry collaborations. Support retailer and other key stakeholder relationships Client groups include US and WW marketing; medical; sales and customer support; R&D; public affairs, public relations and policy; WWBD Qualifications: The candidate must have the following qualifications, skills, and attributes

The Director also provides guidance on legal and regulatory issues related to advertising labeling...

Senior Specialist, Regulatory Affairs Tracking Code 1044 Job Description Job Summary As we approach the commercialization phase of our first product, DX-88, a novel therapeutic for the treatment of Hereditary Angioedema, Dyax is adding new skill sets to our Development teams to meet this exciting new stage of evolution in the organization. The Senior Regulatory Affairs Specialist will participate to regulatory submission strategy, planning and implementation for Dyax products worldwide. This role will play a

Knowledge and Ability Requirements Good understanding of legal and regulatory compliance regulations Knowledge of Federal...

on resources Liaison with Corporate Compliance Primary Legal Contact for Alliance Management audits U S...Business Transactions L D team and other Legal Platforms to ensure consistency in approach and...Lead Counsel US Trade Relations Group Primary legal support for U S...

ImClone Systems is dedicated to developing and commercializing novel therapeutic products in the field of oncology. Our efforts have resulted in a commercially available novel therapy, ERBITUX (cetuximab), as well as a broad spectrum of innovative product candidates with potential application in multiple tumor types. As a member of the oncology community, we are committed to providing treatments to meet the unmet needs of cancer patients. To fulfill this commitment, ImClone Systems fosters integration of

Allergan Medical, a division of Allergan, Inc., located in Santa Barbara, California offers the most comprehensive, science based portfolio of Total Facial Rejuvenation products available, including BOTOX Cosmetic; hyaluronic acid and collagen based dermal fillers; and physician dispensed skin care products. Allergan Medical also offers the industrys widest range of breast implant options for reconstructive and aesthetic breast surgery, and leading minimally invasive devices for obesity intervention treatment

Knowledge and Ability Requirements Good understanding of legal and regulatory compliance regulations Knowledge of Federal...

DUTIES AND RESPONSIBILITIES: - Coordinate the compilation of documents needed to file an ANDA/NDA with the FDA and obtain approval. This includes obtaining information from many departments as well review and approval of specifications, test methods, stability protocols, and batch records. - Respond to any and all deficiencies received on an application through out the course of approval and post-approval within the designated timelines. - File post-approval supplements to an application

Work Location United States New Jersey Company Legal Entity USA Sandoz Inc Princeton NJ Posting...

Primary Role: The Associate Director of Regulatory Affairs will formulate and implement regulatory strategy, provide guidance to program teams and sub-teams, resolve complex issues related to assigned projects, and assure compliance with timelines and milestones to meet business needs. Primary roles include: Utilizing regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to program teams and sub-teams. Acting

Merz is an independent German pharmaceutical company with its own research and development, focused on drugs for the treatment of illnesses in the fields of neurology and psychiatry. Another field of competence is the clinical and aesthetic dermatology. Merz Pharmaceuticals is growing and we have multiple openings in Regulatory Affairs for individuals with either pre-marketing or post-marketing experience. We have new, exciting products in our pipeline that represent opportunities for career advancement and

Merz is an independent German pharmaceutical company with its own research and development, focused on drugs for the treatment of illnesses in the fields of neurology and psychiatry. Another field of competence is the clinical and aesthetic dermatology. Merz Pharmaceuticals is growing and we have multiple openings in Regulatory Affairs for individuals with either pre-marketing or post-marketing experience. We have new, exciting products in our pipeline that represent opportunities for career advancement and

Merz is an independent German pharmaceutical company with its own research and development, focused on drugs for the treatment of illnesses in the fields of neurology and psychiatry. Another field of competence is the clinical and aesthetic dermatology. Merz Pharmaceuticals is growing and we have multiple openings in Regulatory Affairs for individuals with either pre-marketing or post-marketing experience. We have new, exciting products in our pipeline that represent opportunities for career advancement and

Primary Role: The Associate Director of Regulatory Affairs will formulate and implement regulatory strategy, provide guidance to program teams and sub-teams, resolve complex issues related to assigned projects, and assure compliance with timelines and milestones to meet business needs. Primary roles include: Utilizing regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to program teams and sub-teams. Acting

Overview: This position will be working on a Temporary or Consultant basis at Medicis Technologies Corporation A Subsidiary of Medicis Pharmaceutical Corporation in Bothell, Washington. This individual will report to the Vice President, Regulatory Affairs and Quality Systems. Responsibilities: Contingent Staff will be responsible for: - Support ongoing information requests to support and maintain the Canadian MDL - Develop submissions to the US FDA for new product filings - Develop marketing submissions

Covance is expanding its biotechnology services business to the United States. This is an exciting opportunity to get in on the ground floor of a rapidly growing scientific service offering with one of the world s premier drug development companies. The biotechnology business unit will provide a comprehensive portfolio of contract GLP and GMP laboratory services supporting the development and manufacture of biotechnology, biopharmaceutical and vaccine products. It is a great time to join Covance! We are

Meet the new Merck. A stronger pipeline. More products to help people in more ways. More passionate than ever about what matters to our customers. Merck and Schering-Plough are now one company. We recently merged to create a stronger, more diverse and more truly global company. This not only benefits our company and our shareholders, but it also benefits the millions of people around the world who rely on our products and expect us to continue to deliver exceptional value. Our ability to excel depends on

The Sr. Compliance Associate QA, Post Marketing Surveillance is responsible for performing procedures associated with the following Quality Systems ensuring continued cGMP compliance: Product Quality Complaint Product Quality Review / Annual Product Review Product Stability Monitoring Primary Role (Approximately 90% of Time) The Sr. Compliance Associate QA, Post Marketing Surveillance is responsible for one of the three Quality Systems below (primary role), and is responsible to support the

2009 9 23 15 PM Functional area Legal Location Research Triangle Park North Carolina Required...

2009 10 03 49 PM Functional area Legal Location Upper Merion Pennsylvania Required degrees Not...Must communicate effectively with scientific business and legal staff management...Drafts renders legal opinions such as freedom to operate patentability...

Covance is expanding its biotechnology services business to the United States. This is an exciting opportunity to get in on the ground floor of a rapidly growing scientific service offering with one of the world s premier drug development companies. The biotechnology business unit will provide a comprehensive portfolio of contract GLP and GMP laboratory services supporting the development and manufacture of biotechnology, biopharmaceutical and vaccine products. It is a great time to join Covance! We are

Meet the new Merck. A stronger pipeline. More products to help people in more ways. More passionate than ever about what matters to our customers. Merck and Schering-Plough are now one company. We recently merged to create a stronger, more diverse and more truly global company. This not only benefits our company and our shareholders, but it also benefits the millions of people around the world who rely on our products and expect us to continue to deliver exceptional value. Our ability to excel depends on

Position Description: Manages the continued development and implementation of patent strategy. Identifies and pursues valuable intellectual property generated in a dynamic research and development environment. Conducts patent freedom to operate analyses and due diligence analyses. Tasks and Responsibilities: Responsible for pre-patent filing review, providing advice to the company concerning the patent viability of its inventions and the advisability of filing patent applications covering the company s

Manager/Senior Manager, Regulatory Operations and Systems Tracking Code 6208 Job Description Please note that Cubist will be participating in the Regulatory Affairs Professionals Society (RAPS) Virtual Career Fair on Thursday, November 12th. For more information, please visit http://www.raps.org/personifyebusiness/CareerDevelopment/RAPSVirtualCareerFair/tabid/989/Default.aspx. Position Description: Manages the publishing, transmittal, and archiving of regulatory correspondence and submissions in both electronic

Cubist Pharmaceuticals (NASDAQ: CBST) is a biopharmaceutical company focused on the research, development and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. Founded in 1992, Cubist is headquartered in Lexington, MA. Description Manages the publishing, transmittal, and archiving of regulatory correspondence and submissions in both electronic (eCTD) and hard-copy formats, in compliance with current and emerging regulatory requirements. Also manages

Amgen (NASDAQ:AMGN), a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve patients. Job Summary: This role will lead the development of regulatory strategy for International Expansion (IE) commercialization and life cycle management of

Req 09 040 TITLE Director of Legal Affairs LOCATION Rockville MD Novavax Inc...a proactive smart and collaborative Director of Legal Affairs to provide a broad spectrum of...the ability to manage collateral areas of legal responsibility that become relevant through the company...

Monitor current and proposed regulatory and legal issues through external meetings workshops and the Internet...

and internal controls to comply with applicable legal regulatory and McKesson standards and ensure that... Ability to comprehend complex legal matters Ability to successfully influence others A...policies procedures the Director must understand the legal business compliance records and information management and...

and internal controls to comply with applicable legal regulatory and McKesson standards and ensure that...policies procedures the Director must understand the legal business compliance records and information management and...s business units Ability to comprehend complex legal matters Ability to successfully influence others A...

and internal controls to comply with applicable legal regulatory and McKesson standards and ensure that...policies procedures the Director must understand the legal business compliance records and information management and...s business units Ability to comprehend complex legal matters Ability to successfully influence others A...

and internal controls to comply with applicable legal regulatory and McKesson standards and ensure that...s business units Ability to comprehend complex legal matters Ability to successfully influence others A...policies procedures the Director must understand the legal business compliance records and information management and...

Since 1975, Mikart has been a recognized leader in providing contract manufacturing and packaging services to the pharmaceutical industry. We offer a broad range of capabilities encompassing product development, analytical services, and solid and liquid oral dose manufacturing, packaging and regulatory services. We are currently seeking qualified candidates to join our Regulatory Submissions team in the following position: R&D Regulatory Submissions Manager: As a member of our R&D team, you will

USA Work Location United States Massachusetts Company Legal Entity USA Novartis Institutes for BioMedical Research...

Type Permanent Job Description This position provides legal services and counsel to Novartis Consumer Health...Health Inc Parsippany NJ Posting Functional Area Legal Job Type Full Time Employment Type Permanent...Work Location United States New Jersey Company Legal Entity USA Novartis Consumer Health Inc Parsippany...

Health Inc Parsippany NJ Posting Functional Area Legal Job Type Full Time Employment Type Permanent...Work Location United States New Jersey Company Legal Entity USA Novartis Consumer Health Inc Parsippany...

Business Unit Over The CounterDivision Consumer HealthCompany Legal Entity USA Novartis Consumer Health Inc Parsippany...

electronic regulatory submission software preferred familiarity with legal medical and scientific terminology...Familiarity with legal scientific and pharmaceutical related terms and basic...

Clearance Committee CCC process by working with Legal Medical Marketing and Commercial Operations to assure...

COMPLIANCE SPECIALIST Immediate opening for a Compliance Specialist responsible for monitoring the biomedical center process; ensuring overall compliance with company operating procedures as well as any other applicable state, federal or international regulatory requirements. Will assist the regulatory department in internal and external audits to monitor facility compliance with company procedures and policies, SOP's, OSHA, FDA as well as other regulatory agencies. Responsible for reporting compliance