Regulatory Affairs Specialist (130000067C)- Abbott

Job Description  Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people. MAIN PURPOSE: For defined therapeutic areas of responsibilities, will provide regulatory and product registration support to the affiliate for new product registrations as well as regulatory support for ongoing renewals, variations and maintenance on registered products. Maintain local SOPs and Regulatory policies and provide support to the commercial team on marketing activities. MAIN RESPONSIBILITIES: Regulatory ·         Primary contact with HSA : ü       Maintain and strengthen communication with appropriate offices of Health Sciences Authority of Singapore (HSA). ü       Up-to-date product registration, variation, line extension and other related law & regulations knowledge. ü       Monitor and disseminate information on changes related to HSA : laws & regulations affecting registration, manufacture, distribution and sale & marketing of Abbott products. ü       Facilitate communication between headquarter and HSA. ·         Product registration and approval : ü       Develop registration strategies, prioritizing assignments; implement regulatory plan and coordinate multiple projects and activities in accordance with strategic company objectives, annual plan and LRP targets. ü       Review, analyse and coordinate data for new product submissions, line extensions according to priorities and responses to deficiency letters. Ensure that the content comply with government regulations prior to submission to Health Department. ü       Maintain an awareness of country’s regulatory legistration and assesses its impact on Abbott’s business. ü       Monitor progress of marketing applications through the regulatory system. ü       Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals. ·         Product maintenance : ü       Up-to-date of product registration, variation, line extensions and other related law & regulations knowledge. ü       Review, analyse and co-ordinate data for variations submission to marketed products according to priorities and responses to deficiency letters. ü       Monitor progress of variations approval process within HSA. ü       Liaise and negotiate with relevant authorities to facilitate and secure expeditious regulatory approvals. ·         Local SOPS and policies : ü       Prepare and maintain local SOPs and policies relevant to Regulatory Affairs to comply with Abbott global SOPs & policies and HAS requirements. ·         Support to marketing activities : ü       Monitor the progress of marketing applications and provide management with a monthly registration status in S&OP meeting and NPI. ü       Provide regulatory input and support for marketing plans, product launches and other cross-functional activities. ü       Review and provide input and approval on promotional materials, product information, packaging and labels for regulatory compliance. Pharmacovigilance ·         Be the backup for Affiliate Safety Representative (ASR). ·         Be the backup for QA of Hong Kong. Quality Assurance Perform QA functions as the back-up QA personnel. Monitor & audit the supplier, warehouse, secondary assembly activities and distributor and ensure that their activities are compliant with local authority requirements & Abbott standards. Ensure Quality systems are in place and meet standard requirements for Singapore affiliate. Prepare and maintain local SOPs and policies relevant to Quality Assurance to comply with Abbott global SOPs & policies and Singapore laws requirements.   Qualifications   EDUCATION : ·         University degree in pharmacy is preferred ·         Minimum 3 years pharmaceutical industry experience in regulatory affairs preferred ·         Understands business needs and impact of regulatory issues ·         Interpersonal skills ·         Communication skills, both oral and written             ·         Experience in regulatory documentation required to support regulatory submissions     Job Classification : Experienced Job : COMPLIANCE/REGULATORY AFFAIRS Primary Location : Singapore-Central Singapore-Singapore Organization : EPD-EstPharmDiv Schedule : Full-time Shift : Day Travel : No

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