Senior Regulatory Affairs Specialist

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.

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.

- 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.