Aug
7
Regulatory Affairs Manager
August 7, 2022 | Comments Off on Regulatory Affairs Manager
Regulatory Affairs Manager
Shanghai
Competitive Salary + Benefits + Bonus
If you are an experienced Regulatory Affairs professional with a deep understanding of the Chinese pharmaceutical regulatory landscape then we want to hear from you!
Join us to help improve peoples' lives and make healthcare better for everyone!
We are looking for a talented, dynamic, and motivated Regulatory Affairs Manager to support the expansion of our business in China.
Reporting to the Head of Regulatory Affairs based in the UK, you will be responsible for the regulatory compliance of our China product portfolio and play a critical role providing strategic advice on regulatory risks and opportunities to support our growth and innovation in China.
Why Pharmanovia?
Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 140 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.
Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 250 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.E., India, Singapore, Italy, and South Korea.
We are an agile and imaginative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.
Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.
About the role:
Our regulatory department is responsible for providing regulatory strategic advice and life cycle maintenance for the portfolio, globally, and in addition supports with new product development initiatives.
Main responsibilities:
- Serving as a primary RA expert and contact for the local health authority (HA(s), local consultancies/ distributors and internal stakeholders, to ensure timely and accurate submissions
- Providing strategic and operational regulatory support on new projects
- Ensuring all existing and new drug products comply with the updated China authority requirement and registration approval
- Maintaining product license & approval and variation application registration and approval in terms of business needs
- Prepare and submit registration dossier and deficiency response timely in terms of company internal data and comply with China regulatory requirement and guidelines
- Leading the preparation of core dossiers and submissions
- In collaboration with global partners, consultancies and distributors, outlining regulatory intelligence
- In collaboration with senior management and project strategy teams, developing and reviewing cross functional regulatory strategies
- Define regulatory strategic plans for innovative product development
- Ensuring diligent reporting and progress updates on regulatory workload at weekly/bi-weekly internal regulatory meetings
- Negotiating and making agreements on behalf of the company
- Interpreting applicable regulations and guidelines for project team use, keeping project team abreast of regulatory decisions, evolving regulatory requirements, risks and mitigation plans
About you:
- A Bachelor's degree in pharmacy, nutrition, chemistry, pharmacology, or related life sciences
- Experience gained in pharmaceutical regulatory affairs
- Experience gained in maintaining and enhancing current marketed drug product approval
- Significant experience of interfacing with government regulatory agencies and proven skill at developing and implementing successful China regulatory strategies
- Experience of a broad range regulatory work in the pharmaceutical industry
- Experience working in a complex and matrixed environment is required
- Up to date knowledge of drug legislation and regulations
- Fluent spoken and written English
What we offer:
We offer a competitive salary plus bonus
By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.