Senior Regulatory Submissions Specialist I

Job Category: Quality Assurance/Safety 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 Coordinates and facilitates regulatory aspects of projects/products, including the preparation and submission of regulatory related documents to regulatory agencies. Represents the regulatory function on teams, providing regulatory knowledge and strategy input to ensure effective business outcomes. Job Responsibilities *Facilitates the regulatory aspects of projects/products, including documentation submitted to regulatory agencies and regulatory agency interactions. Ensures that the documentation is complete and complies with applicable regulatory requirements. *Provides input to regulatory strategies for global product development, CMC, labeling or promotional issues, and recommends actions based on strategies to RA Team Leader, Team Members and/or supervisor. *Interfaces with multiple departments within Wyeth to provide guidance and expertise on assigned products/projects. Interfaces with Boards of Health (BoH) personnel as member of a team to facilitate the review and approval of regulatory documentation. Interacts with external customers (Trade Organizations, Wyeth business partners, etc.) to enhance Wyeth strategy. *Reviews documentation from departments outside Regulatory Affairs. With supervisor and/or team consultation provides guidance as to acceptability of the regulatory strategy presented. *Participates on RA Teams or committees as team member. Serves as GRA representative to Interdepartmental development or brand teams. *Provides input to analyses of regulatory guidance documents, regulations, or directives that impact Wyeth products and operations. Advise personnel in other departments regarding their applicability and impact. Basic Qualifications *BS 5-6 yrs, MS/PharmD 3 yrs. *Training in accordance with GRA Training curriculum (SOPs, SPIs, Policies) and ‘on the job’ training/learning. *3 yrs regulatory-related or equivalent experience required. Demonstrated accomplishments will be evaluated and substituted for extent of experience, as needed. 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-PA-Collegeville Leading the way to a healthier world.