Labeling Lead Global/EU/US
Labeling Lead Global/EU/US
Anneessensstraat 3-5 , Antwerpen, Belgium
PhaRA is a leading consultancy firm in Regulatory Affairs located in the Benelux. Focusing exclusively on regulatory affairs, PhaRA offers in-depth expertise and skills covering a broad range of RA activities throughout product development and life cycle for chemical entities and biologicals. Established in 2002, our renowned PhaRA team has an impressive track record of successful registrations and projects. Our consultants highly value the broad range of roles and projects they can take on, as well as the variable client settings in which they can operate. Talent development and know-how sharing are at the heart of our strategy, acknowledging needs for personal flexibility and ambitions. For more information, visit www.phara.eu.
We are seeking to strengthen our team with an enthusiastic, motivated, hands-on yet experienced Labeling Lead with at least 5 years of scientific product labeling experience or equivalent (eg, regulatory affairs, medical information, pharmacovigilance, medical writing).
You will support our clients in the development of sound labeling strategies.
You manage labeling content from all stages of a product’s life cycle, from target labeling in the early development phase of a product, providing support with agency interactions, to the maintenance of product information of marketed products.
You will participate in or steer client project teams in an international environment.
You lead labeling discussions to facilitate the development and maintenance of labeling deliverables.
You offer creative solutions and strategies, make appropriate recommendations/decisions, including risk mitigation strategies.
You manage timelines to achieve high-quality product information.
You serve as a labeling subject matter expert for colleagues and clients.
You may also be assigned to submissions of new marketing authorization applications and the maintenance of existing marketing authorization applications or other regulatory procedures.
You report to PhaRA’s senior management team.
By growing and sharing your expertise with PhaRA colleagues and client teams, you eventually fulfil the unmet need of patients.
Master or PhD in life sciences with at least 5 years of experience in scientific and strategic global labeling. Alternatively, extensive relevant expertise in medicinal product development and/or life cycle management (eg, regulatory affairs, medical information, pharmacovigilance, medical writing), in large to midsize pharmaceutical companies, consultancy firms, and/or health authority with a keen interest in global labeling.
Product labeling experience should include authoring text for product labeling (CCDSs, EUPIs, and/or USPIs), including drafting text based on scientific source data, liaising with and advising cross-functional experts and regulatory professionals on labeling compliance and strategic labeling plans, and facilitation of labeling negotiations with health authorities.
Strong scientific interest and background allowing to understand complex scientific data in several areas of drug development (quality, non-clinical, clinical) and frame these in a regulatory context. Experience in specialized areas of medicinal product development such as biologicals, infectious diseases, oncology, immunology or other is a plus.
Excellent analytical and problem-solving skills paired with organizational skills and resilience to manage multiple projects and changing priorities.
Determination and excellent project management skills to deliver according to deadlines and high-quality standards.
Inspiring leadership towards external and internal clients.
Experience with company stakeholder interaction.
Excellent written and oral communication skills in English are a must in order to drive meetings and author documents. Knowledge of Dutch and French is considered a plus.
Proactive and “can do” attitude.
Customer minded and quality output driven.
A highly motivated, dynamic person and team player who can operate in a flexible and often virtual working environment.
A clear commitment to stay tuned in a rapidly changing innovative regulatory environment.
Pleasant personality with effective interpersonal skills.
While interacting constantly with major pharmaceutical companies and biotech SMEs, you are part of a young and dynamic team and an informal culture.
A competitive salary and extra benefits.
A varied job where you can take on different kinds of projects in a very broad range of therapeutic areas.
Exchange of expertise with other experienced regulatory affairs colleagues, passionate for regulatory affairs.
A clear commitment to invest in expanding your knowledge and personal growth.
PhaRA is based in Antwerp, Belgium, with excellent accessibility by public transport (literally 5 minutes' walk from Antwerp Central Station). Your job may require regular commutes to clients or occasional working from a client’s premise. To us, working from home was common before covid-19 and we are fully equipped to continue to do so. We nevertheless believe in the benefits of real-life contact and face-to-face knowledge-sharing, learning and mentoring.