Senior Regulatory Specialist I

Job Description:At Wyeth, we have a vision of leading the way to a healthier world. We've committed ourselves to achieving this vision by making quality, integrity and excellence the hallmarks of our business. A Fortune 500 company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that our employees are who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop and motivate individuals whose skills, values, and work ethic will grow and improve our business. Senior Regulatory Specialist IWyeth PharmaceuticalsCambridge, Massachusetts (Boston, MA)Requisition 21297 Job SummaryCoordinates the preparation and submission of correspondence and applications to regulatory agencies, and acts as direct liaison with regulatory authorities to facilitate the prompt review and approval of applications. Participates on Regulatory Teams for assigned projects/products.Job ResponsibilitiesPreparation, review and submission of regulatory documents that are complete and properly formatted, and in compliance with local regulations.Contribute to the development of effective proactive regulatory strategies for global product development and labeling issues, and recommends such strategies to Regulatory Affairs (RA) Team Leader, Team Members and/or supervisor, as appropriate.Interface directly with governmental regulatory personnel, including scientific reviewers and administrative personnel, to facilitate the review and approval of regulatory applications.Review documentation from departments outside Regulatory Affairs. Provides advice on regulatory acceptability of plans for drug development and labeling through individual as well as RA Team and Interdepartmental Project Team contacts.Prepare interpretive analyses of key regulatory guidance documents, regulations, or directives that impact Wyeth-Ayerst products and operations. Advises personnel in other departments regarding their applicability and impact.Participate on RA Teams or committees; may lead RA Team depending on individual skills and experience. May serve as principal WWRA representative to Interdepartmental development or brand teams.Basic QualificationsBachelors Degree, preferably with a Science.At least 5 years of relevant pharmaceutical experience, or at least 2 years with a Masters Degree, or a Doctorate Degree.At least 3 years regulatory experience.Experience with oncology products is preferred.Relocation assistance is not available for this position.If you are not viewing this from our career web site, go to https://wyeth.recruitmax.com/main/careerportal/login.cfm, click on the ''Job Search'' tab, use Keywords: ''21297'' for a search, click on the ''Job Title'' link and then ''Apply To This Job'' at the end of the page. If you are unsure whether or not you already have a candidate profile in our database, request your forgotten password before attempting to create a new one. Please make sure that you have both a text version of your resume in the appropriate field as well a Word version attached to your profile.Wyeth offers competitive compensation and benefits programs, including child-care subsidies, flex-time, business casual attire, educational assistance and professional development programs. For more information and to apply online, please visit us at: www.wyeth.com/careers Wyeth is an Equal Opportunity Employer, M/F/D/V. Search Firm Representatives: Please Read Carefully. Wyeth is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Wyeth via-email, the Internet or directly to hiring managers at Wyeth in any form without a valid written search agreement in place for that position will be deemed the sole property of Wyeth, and no fee will be paid in the event the candidate is hired by Wyeth as a result of the referral or through other means. Note: Any search agreement entered into with Wyeth prior to January 2004 is hereinafter void. Search firms are essential to the recruitment and staffing efforts at Wyeth and we value the partnerships we have built with our preferred vendors. For this reason, Wyeth has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Vice President, Strategic Staffing at Wyeth in place for the specific position in order for a fee to be paid for any candidate referrals.Job Experience:See above.Expected Travel Time: None       www.wyeth.com/careers Wyeth is an equal opportunity employer that shares the vision of a diverse workplace. Search Firm Representatives: Please Read Carefully. Wyeth is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Wyeth via-email, the Internet or directly to hiring managers at Wyeth in any form without a valid written search agreement in place for that position will be deemed the sole property of Wyeth, and no fee will be paid in the event the candidate is hired by Wyeth as a result of the referral or through other means. Note: Any search agreement entered into with Wyeth prior to January 2004 is hereinafter void.Search firms are essential to the recruitment and staffing efforts at Wyeth and we value the partnerships we have built with our preferred vendors. For this reason, Wyeth has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Vice President, Strategic Staffing at Wyeth in place for the specific position in order for a fee to be paid for any candidate referrals.