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Senior Manager Regulatory Affairs
September 5, 2023 | Comments Off on Senior Manager Regulatory Affairs
Senior Manager Regulatory Affairs
Based in Basildon, hybrid working
Salary: Competitive + Benefits + Bonus
If you are a strategic Regulatory Affairs Senior Manager with great leadership skills then we want to hear from you!
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.
Our core behaviours are:
- We act decisively but we never compromise on quality.
- We keep our promises and do as we say.
- We value our heritage and foster an entrepreneurial spirit.
- We reinvest in our future - in our products, our brands and our people.
- We give back to our communities.
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 300 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, committed, and innovative 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:
You'll be a key member of our regulatory team. Our regulatory department is responsible for providing regulatory strategic advice, dossier authoring support and life cycle development for our portfolio.
Your responsibilities will include:
- Providing strategic and regulatory leadership 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
- Writing, reviewing and approving impact assessments, M3 dossier sections, bioequivalence waivers and scientific justification documents as well as master production documents from CMOs.
- Ensuring diligent reporting and progress updates on regulatory workload at weekly/bi-weekly internal regulatory meeting
- Working closely with the project team and keeping them abreast of regulatory decisions, evolving regulatory requirements, risks and mitigation plans
- Mentoring and managing Regulatory Managers, Regulatory Associates and other junior level or administrative Regulatory staff including interviewing, hiring, and training employees; planning, assigning, and overseeing regulatory submissions
About you:
- Your experience should be broad / regulatory experience gained within a pharmaceutical company, CRO, CMO or similar organization with particular focus on CMC.
- Experience in line management
- You should enjoy developing a team, training and supporting personal development plans
- Strong knowledge of EU regulatory framework and guidelines
- Able to negotiate comfortably and effectively with regulatory authorities
- Aware of emerging markets submission rollouts
- Expertise in regulatory submission structure and content (e.g. MAA, NDA)
- Experience in compliance and maintaining product life cycle data bases and RIMs systems
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 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.