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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.
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.
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.
Key Responsibilities:- Help build the regulatory strategy and plans for projects in the pipeline with focus on clinical and non-clinical aspects of the dossier.
- 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.
- 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.
- Authoring and reviewing the clinical sections of the dossier 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.
- Build the orphan drug submission strategies and the scientific clinical rationales to support the strategies.
- 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.
- Identification and management of external consultants.
- 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 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.
- 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.
- Excellent oral and written English communication.
We offer a competitive salary plus bonus and rewards package including holiday, health & well-being program, employee recognition awards, social events, pension scheme and hybrid working.
