Jul
22
Regulatory Affairs Manager
July 22, 2022 | Comments Off on Regulatory Affairs Manager
Regulatory Affairs Manager - Written and Spoken Mandarin
Based in London / Basildon - Hybrid or remote working for the right applicant.
Salary: Competitive + Benefits + Bonus
If you are an experienced Regulatory Affairs Manager with written and spoken Mandarin/Chinese then we want to hear from you! Join us to help improve peoples' lives and make healthcare better for everyone!
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. Reporting into the Therapeutic Area Leads, as the Regulatory Manager your role is varied and broad ranging:
Main responsibilities & duties:
- Providing strategic and operational regulatory support to project management on new divestment projects, technical transfer, CMOs, quality assurance and commercial departments
- Leading the preparation of core dossiers and submissions for global roll out
- Authoring, reviewing and approving M3 dossier sections as necessary, justification documents and product information
- In collaboration with global partners, consultancies and distributors, outlining global regulatory intelligence and form a global regulatory strategy
- In collaboration with senior management and project strategy teams, developing and reviewing global 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 department
- Interpreting applicable regulations and guidelines for project team use, keeping project team abreast of regulatory decisions, evolving regulatory requirements, risks and mitigation plans
- Serving as a primary contact to the local health authority (HA(s), local consultancies/ distributors and internal stakeholders, to ensure timely and accurate submissions
- Facilitating communication between the HA(s) and the project team, attending and generally leading agency meetings, if required
- Coordinating and soliciting components of the submission from various functional areas, distributors and CMOs
- Proactively identifying project issues to the project team and supporting mitigation plans
- Attending cross functional meetings, vendor meetings and kick-off meetings as required
- Mentoring and/or managing other Regulatory Managers, Regulatory Associates and other junior level or administrative Regulatory staff
- Maintaining a high level of professional expertise through familiarity with scientific literature and participation in training courses
- Other responsibilities may include interviewing, hiring, and training employees; planning, assigning, and overseeing regulatory submissions
About you:
You have a strong, generalist regulatory background gained as a manager within a pharmaceutical company, CRP/CMO or a similar organisation. You will also have:
- Bachelor's degree in life sciences
- Excellent communication skills
- IT skills including MS Word, Excel, PowerPoint, Project and Outlook
- Strong knowledge of EU regulatory framework and guidelines
- Awareness of emerging markets submission rollouts
- Experience with SmPC updates, labelling processes and artwork approval
- Expertise in regulatory submission structure and content (e.g., MAA, NDA)
- Experience in compliance and maintaining product life cycle databases and RIMs systems
- Experience in making global regulatory strategy and deployment decisions and strategic priorities
- Ability to work successfully both independently and within a cross-functional team
- Mandarin - written and spoken
What we offer:
We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid / remote working.
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.