Job Description:The Senior Regulatory Affairs Consultant will provide regulatory and product development support to Novotech stakeholders, both internal and external, including managing Client projects. Primarily, activities will focus on regulatory work and strategy that facilitates the entry of Clients' compounds into clinical trials.The Senior Regulatory Affairs Consultant will lead activities required to obtain clinical trial and/or marketing approval in multiple regulatory jurisdictions. Practically, this includes the drafting and review of regulatory documents such as briefing packages for meetings with regulatory agencies, clinical trial application documents e.g. INDs and license applications for genetically modified organisms (GMOs) and marketing applications. Direct communication with Health Authorities such as attending scientific advice meetings will be required.
Key Responsibilities- Develop and implement regulatory strategies for product development and commercialization within the ANZ / APAC region and globally.
- Provide expert guidance on regulatory requirements and compliance for pharmaceutical, biotech, and advanced therapies.
- Lead and guide cross-functional teams to ensure alignment of regulatory strategies with phase appropriate drug development requirements.
- Monitor and interpret regulatory trends, policies, and guidelines to keep the company's regulatory strategies current and effective.
- Build strong relationships with internal and external stakeholders and other project team members to ensure high-quality work and timely delivery of documents.
- Act as the local regulatory agent and communicate directly with the Health Authorities as required, including attendance at scientific meetings.
- Participate in business development meetings with Clients and review proposals generated by the Business Development team as required.
Required Expertise and Qualifications:
- ANZ / APAC Regulatory Knowledge: Deep understanding of regulatory requirements and processes specific to the ANZ/APAC region.
- Advanced degree in Life Sciences, Regulatory Affairs, or a related field.
- Minimum of 5-8 years of experience in regulatory affairs, with a focus on strategy and early-phase drug development expertise (late-phase regulatory expertise a plus!).
- Global Regulatory experience would be highly regarded: Experience / exposure working with global regulatory bodies such as the FDA, EMA, MFDS, and other international agencies.
- Ability to work effectively and independently in a fast-paced environment with multiple high priority projects under tight timelines.
- Strong proficiency in English usage (both verbal and written with grammar, punctuation, language)
- Must have excellent customer-service orientation.
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.About Us: Novotech has offices in 11 geographies across the region, and site partnerships with key medical institutions.Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.About the Team: Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services.It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.As of September 30, 2021, Novotech had over 2,750 FTEs across 11 geographies in Asia-Pacific, the United States and the UK.
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