Manager, Global Regulatory Affairs

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. JOB SUMMARY: By working at Wyeth, you can help others to live longer, more fulfilling lives while realizing other important professional objectives. Discovering and developing innovative products in the areas of pharmaceutical, biotechnology, consumer healthcare, nutritional and animal healthcare, our global organization is dedicated to making the world a healthier place to live. Wyeth has a long-standing value of respect for people that promotes a diverse culture and an environment of mutual respect for our employees, customers, and communities. As a global corporation, Wyeth is committed to cultivating a diverse workplace where individuals from different backgrounds, experiences, and viewpoints are valued. We currently have a career opportunity at our Madison, NJ headquarters for a Manager, Global Regulatory Affairs.JOB RESPONSIBILITIES: Participate in the development of global regulatory strategy; provide regulatory advice and guidance to the therapeutic product teams, the business units, corporate legal and to the regulatory leadership team on chemistry, preclinical, clinical, labeling, advertising/promotion or compliance for new and existing products. Represent global regulatory affairs at the product team or other meetings requiring regulatory guidance, compliance or policy issues. Oversee and approve new and revised labeling for products. Research and interpret OTC monographs (both TFM and final), and other relevant rulemakings for the development of label content. Direct the preparation of labeling, preclinical and clinical sections for submission to regulatory bodies or external agencies: identify and rectify deficiencies and notify management for concurrence with discussion of resolution.BASIC QUALIFICATION: Bachelor’s Degree required. BS in life sciences preferred 3-5 years regulatory generalist experience, including IND/NDAs Experience in the post-marketing area; filing of supplements, review and submission of advertising to DDMAC in Rx or OTC Experience with eCTD desired Relocation is not available for this position.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.Expected Travel Time: None Zip Code :US-NJ-Madison Leading the way to a healthier world.