Associate Manager CMC
2 weeks ago
Description Kenvue is currently recruiting for: Associate Manager, Global Regulatory CMC This position reports into Manager Regulatory Affairs and is based at Bangalore. Who We Are At Kenvue , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made up with 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you Join us in shaping our future-and yours. For more information, click here . What You Will Do This is a global role with an initial primary focus on EMEA and Asia Pacific markets. Global brand under the supervision of the Manager, and as a representative of the Global Regulatory Affairs organization. Key Responsibilities • Partner with R&D, QA, Operations, Business Units and other stakeholders to develop regulatory strategies for health authority submissions or other product related activities. • Contribute to and implement regulatory strategies to ensure documentation is available for filings (e.g., New product registrations, Variations, Responses to Questions), as appropriate. • Assess compliance of product (formulations, manufacturing processes, packaging, specifications, etc.) with filings and propose CMC mitigation strategies. • Identify the required documentation for CMC submissions and negotiate the delivery of approved technical source data/documents in accordance with project timelines. • Write high-quality CMC documents, contribute to CMC regulatory strategies, assure technical congruency and regulatory compliance by meeting agreed submission deadlines. • Preparation, review, submission, approval, and maintenance of CMC sections for regulatory filings (CTA's, MAA's, variations, renewals, etc.) • Review post-approval changes (change controls), assess the regulatory impact on affected registrations and provide CMC support to write/collate relevant variation packages. • Work collaboratively with global CMC colleagues and as required, provide supervision of CMC support to them. • Provide input to refine/develop processes relating to regulatory submissions and regulatory aspects of product development and maintenance. • Train and educate colleagues/business partners with respect to regulatory requirements. • Assist in overseeing CMC activities performed by colleagues/business partners • Maintain regulatory work processes and tracking tools that improve performance levels and transparency. • Promote regulatory intelligence in both local and regional initiatives • Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met. • Keep up to date knowledge of quality guidelines and technical trends • Represent company in industry organizations, seminars, workshops, etc. (as assigned) What We Are Looking For Required Qualifications • Minimum B.S. Chemistry, Pharmacy or related scientific field. • Preferred 5 years of relevant work experience • Working knowledge of regulatory requirements, particularly for EU and other countries, (Asia Pacific, Middle east etc) for various drug dosage forms including solids, semi-solids, solutions, sterile products, etc. Experience of regulatory CMC requirements for other global regions is beneficial. • Experience in preparation and maintenance of CMC sections for Health Authority filings (Modules 2.3 and 3, CTD, e-CTD); experience with global dossiers is desirable • Experience with documents needed to support local, regional, and global filing requirements. • Awareness of consumer product categories (e.g., drugs, cosmetics, devices). • Technical/science-based background (QA, manufacturing, laboratory, plant, etc.) • Strong knowledge of GMP and regulatory compliance. • Good interpersonal and written skills. What's In It For You • Competitive Benefit Package • Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More • Learning & Development Opportunities • Employee Resource Groups • This list could vary based on location/region Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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