Medical Director – Regulatory Strategy & Development

Job title:

Medical Director – Regulatory Strategy & Development

Company

Ortolan Group

Job description

• Posted: 17 hours ago
• Reference: Pharmanovia_1724056840
• Title: Medical Director – Regulatory Strategy & Development
• Type: Permanent

• Full or Part-Time: Full-Time
• Industry: Pharmaceuticals
• Location: London, England
• Salary: Negotiable

Medical Director – Regulatory DevelopmentUK or EU based (Hybrid working with some travel) Other locations outside the UK and the EU will be considered for the right applicant.Salary: Competitive + Benefits + BonusIf you are an experienced physician / scientist with regulatory experience 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 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: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.Main 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.
• 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.
• Identification and management of external consultants.
• Attend training lectures, symposia and conferences in order to maintain up-to-date level of knowledge and expertise.

About you:

• 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.
• 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.
• 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 work with internal and external stakeholders in a multicultural and diverse environment with respect and patience.

What we offer: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 the EU will be considered for the right applicant.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.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.

Expected salary

Location

London

Job date

Wed, 21 Aug 2024 04:18:15 GMT

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