Job Information
Hovione Senior Regulatory Affairs Specialist in Beijing, China
Join a Market Leader
Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.
Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.
Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.
You will be responsible to:
Implements and manages the required guidelines and cGMPs for Hovione, providing LEAN based Quality Systems and Tools, controlled, harmonized and aligned with the company’s strategic plan, promoting a rigorous and continuous improvement culture to guarantee high quality compliant sites. Maintains active and efficient communication channels along the several Hovione sites, identifying Quality needs and improvements both from internal and external stakeholders. Evaluates, advises and provides services and technical support, internally and externally, related to the legal and scientific regulatory requirements in relation to product development, commercialization and optimization across the full product lifecycle to ensure compliance with both global and local regulatory legislation, guidelines, inspections, audits and other regulatory due diligence. Represents Hovione through communications and negotiations with regulatory authorities, preparing, submitting and managing all matters related to regulatory submissions and licensing for Hovione and customer products; and within professional associations, industry/trade groups.
Prepare complex and new submissions and manage submissions of existing products throughout the product lifecycle, in current and new markets
Execute complex pre and post approval compliance activities aligned with the company strategic plan and compliant with standard operation procedures and support less experienced colleagues
Submit applicable reports and ensure appropriate responses are submitted to regulatory authorities, monitoring the responses and supporting less experienced colleagues
Promote the importance of regulatory compliance throughout product lifecycle with other areas, working with them on complex and multifaceted issues
Provide training on regulatory matters to different areas of the company
Perform complex regulatory services as part of the CMO activities
Participate in inspections / audits, answering questions related to regulatory affairs
Lead shared services compliance activities, supporting less experience colleagues in resolving complex issues
Prepare and ensure that site licenses registration and product import licenses are kept updated
Compile, prepare and review updated regulatory filings to regulatory authorities
Assess and monitor changes, and their impact in the regulatory filings
Prepare and submit complex reports and responses to regulatory authorities
Propose updated strategies upon regulatory changes
Participate in Customer product submissions as part of CMO services (preparation and / or revision of DMF / NDA CTD sections, as contracted by the Customer and assist in the reply to the competent authorities on complex matters)
Verify that the regulatory requirements are followed in the preparation and updating of Hovione or Customer Product Files
Provide complex regulatory technical support to customers (management of requests, preparation of communications and technical packages for customers, coordination of document attestation/legalization, preparation of periodic reports) and support less experienced colleagues in the same
Search and select regularly updated information on legislation, regulations and guidelines, updating the internal processes and sharing information with the wider team
Discuss and provide technical guidance on complex regulatory requirements to other areas
Prepare complex reports and regulatory agency communications
Review and propose improvements to the annual assessment for the submitted filings
Review and prepare complex updated regulatory filings to authorities: amendments / updates / changes / variations, annual reports, responses to deficiency letters or requests for additional information
Actively participate in professional associations, industry/ trade groups (local/regional/ international) and appropriate standards organizations
Manage regulatory affairs databases and tracking systems
Review and propose improvements to regulatory affairs internal procedures
Master Regulatory Affairs processes and tools
Manage complex projects/ analysis with significant impact on business
Make quality and timely decisions based on multiple sources of data
Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals
Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).
Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
We are looking to recruit a Candidate:
University, or equivalent, qualification in Pharmaceutical Sciences or similar scientific field (mandatory)
Typically requires 5-8 years of relevant experience in Regulatory Affairs in the Pharmaceutical Industry
Advanced knowledge of Quality, cGMPs, ICH guidelines, CFR and national and international legislation related to pharmaceutical products with the ability to solve complex problems
Fluency in English is a requirement
Computer literate with good working knowledge of the MS Office package
Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.
Hovione is a proud Equal Opportunity Employer
Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.
(https://en-careers-hovione.icims.com/jobs/10202/senior-regulatory-affairs-specialist/job?mode=apply&apply=yes&in\_iframe=1&hashed=-1834418400)
Hiring Request Post Information* : Posted Date6 days ago(2024/11/18 20:41)
ID2024-10202
of Openings1
Job LocationsCN-Beijing
Job FamilyQUALITY