Pharmanovia is a fast-growing pharmaceutical company with a portfolio of over 20 brands across 140+ markets. Our team of over 200 employees are based globally across offices in the UK, Denmark, Netherlands, Switzerland, U.A.E., India, Australia, Singapore, Italy, South Korea and many more.
Since we first opened our doors in 2013, we have focused on delivering high-quality branded prescription medicines to patients, prescribers and healthcare providers across the globe.
Our purpose is to reinvigorate and innovate iconic medicines for the benefit of patient health globally. We aspire to be an agile and imaginative specialty pharma business and a preferred partner for innovator pharma companies.
Our Therapeutic areas include Cardiovascular, Women’s Health & Endocrinology, Neurology & Pain and Gastroenterology and Oncology.
Our regulatory department is responsible for providing regulatory strategic advice and life cycle maintenance for the portfolio, globally. In addition, support with new product development initiatives.
KEY TASKS & RESPONSIBILITIES:
- Providing operation regulatory support to project manager on new divestment projects, technical transfer, CMO’s quality assurance and commercial departments.
- Supporting regulatory submissions in the EU, US, and ROW markets.
- Producing documentation for submission, including M1 and M3 dossier sections, justification documents and product information.
- Monitoring labelling compliance across multiple markets, coordinates the review of the Company Core Data sheet (CCDS) and subsequent safety updates globally.
- In collaboration with global partners, consultancies, and distributors, supports the compilation of global regulatory intelligence to form a global regulatory strategy.
- Continual communication with local health authorities, local consultancies, distributors, and internal stakeholders to ensure timely and accurate submissions.
- In collaboration with senior management and project strategy teams, supporting global cross functional regulatory strategies.
- Supporting business development and due diligence efforts.
KEY ACCOUNTABILITIES AND QUALIFICATIONS:
- Bachelor’s Degree in pharmacy, biology, chemistry, pharmacology or a related subject.
- At least 10 years of related experience within a pharmaceutical company, CRO or CMO.
- Experience in CCDS and SMPC updates, labelling process and artwork approval.
- Experience of working with regulatory authorities and knowledge of the regulatory framework and guidelines.
- Ability to provide strategic advocacy on key topics relevant for the category and present complex global regulatory strategies internally to our partners.
- Outstanding research and analytical skills.
- Success in working across functional team and evidence of strong collaboration with key business partners.
- Experience of regulatory submissions in the EU, US, and ROW markets would be advantageous.
- Strong IT Skills including MS Software including, Excel, PowerPoint, and Word.
In return, the company offers a competitive base salary and performance-related bonus as well as private healthcare, hybrid working policy, health & wellbeing program, company events, annual employee awards and retailer and gym membership discounts.