UK or EU based (Hybrid working 2-3 days office based + home working)
Salary: Competitive + Benefits + Bonus
If you are a dynamic regulatory leader with expert technical and tactical experience in regulatory strategy in the UK, EU and internationally, then we want to hear from you.
Join us to help improve peoples’ lives and make healthcare better for everyone!
Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 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, Spain, 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:
The Director of Regulatory Development and Strategy reports to the Senior director of product development and works closely with the clinical and medical team, as well as project leaders, product development teams and with the relevant functions throughout the organization.
This is a key role which acts at the interface between the company and the regulatory authorities, through the entire life cycle of the medication, from early development to commercialization across all our regions.
The position can be located in the UK or EU and provides global coverage to the company on various development and acquisition projects. Other locations outside the UK and EU will be considered for the right applicant.
Main responsibilities & duties:
- With the project lead, build the regulatory strategy and plans for the projects in the pipeline with focus on clinical and non-clinical aspects of the dossier.
- Provide leadership and act as SME in implementing registration strategy across relevant groups, including Clinical Development, Preclinical Development, Marketing and CMC.
- Lead and work closely with relevant clinical development, operations and research personnel to ensure regulatory compliance and consistency with regulatory registration strategy.
- Understand the need of clinical study as per requirements of regulatory agencies.
- Support the build of global clinical development strategy based on correct interpretation of regulatory requirements.
- Review and Input into clinical study protocols and reports to support the intended indications in line with regulatory requirements.
- Responsibility of authoring and reviewing the clinical sections of the dossier (modules 5) for regulatory submissions.
- Manage interactions and build positive relationships with all relevant Health Authorities and service providers to facilitate timely and compliant submissions and approvals.
- Advise senior management on regulatory and clinical strategy pathways and options for successful developments.
- With the relevant functions, input into the preparation of the clinical aspect of pre-submission /paediatric investigation/ scientific advice briefing packages.
- Design the regulatory input on clinical sections of clinical trial protocols and strategy for paediatric investigation plans and/or waivers.
- Building the orphan drug submission strategies.
- Literature search and building the scientific clinical rationales to support the strategies.
- Provide support in post-approval clinical commitments (Registry, Phase IV Studies, RWE etc.) and digital projects with regulatory strategy for development.
- Analyse and interpret scientific and clinical data critically to support regulatory submissions and strategies.
- With the medical director, reviews material for communications with external stakeholders, including, promotional materials, press-releases, study ads and relevant media for regulatory compliance
- With the quality lead ascertains the compliance of production with ICH-GCP guidelines and other relevant specifications and regulatory guidance.
- With the product development team, review the clinical sections of the dossier of in-licensing and acquired products and prepare gap assessment reports.
- Identification and management of external consultants – ascertains the utilization of external advice to cover knowledge gaps.
- Maintain high ethical standards and a strong knowledge and understanding of rules, regulations and guidelines – relevant to clinical research, scientific scrutiny and level of evidence and engagement with stakeholders.
- Attend training lectures, symposia and conferences in order to maintain up-to-date level of knowledge and expertise.
- Extensive experience gained in the pharmaceutical industry, ideally from within a consultancy firms, healthcare authority (MHRA, EMA or any other EU Competent Authority) with focus on regulatory affairs and clinical Assessment and Review.
- Experience of development in the UK, EU and RoW.
- Up-to-date knowledge of the regulatory guidelines, a good understanding of the decision-making process in the regulatory authorities and the ability to identify trends and directions that influence the process. The role requires in-depth understanding and engagement with key regulators.
- BSc or higher academic degree (including MD, Clinical Pharmacology, Pharmacy or related scientific qualification).
- Specific experience in late-stage development, clinical authoring and filling of MAA.
- Experience in working with EMA, ODD, PIP, regulatory Scientific Advice Meetings and other relevant technical work EMA, FDA and other Competent Authorities.
- Ability to analyse and interpret clinical study reports and scientific literature and deliver regulatory position papers.
- Experience in identification and management of external consultants.
- Up-to-date ICH-GCP certification.
- Fluent English.
- Excellent oral and written English communication.
- Ability to influence and negotiate effectively.
- Ability to work well in a dynamic and constantly changing environment, with flexibility and agility.
- Ability to combine a strong scientific knowledge and understanding of medical challenges, with focused and value-adding delivery of tasks and commitments.
- Ability to work with internal and external stakeholders in a multicultural and diverse environment with respect and patience.
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.