Junior Regulatory Affairs Manager

02/07/21

Location

Anneessensstraat 3-5 bus 9, Antwerpen, Belgium

Function type

(graduate position)

Vacancy

About us

PhaRA is a leading consultancy firm in EU Regulatory Affairs (RA) located in Antwerp. 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 is at the heart of our strategy, acknowledging needs for personal flexibility and ambitions. For more information, visit www.phara.eu.

To support our growth, PhaRA is looking for an enthusiastic and motivated Junior Regulatory Affairs Manager.

Your job

Starting your career with us, you will work in close collaboration with a Senior colleague - your dedicated mentor - who will support your growth towards a higher complexity of tasks and more autonomy. All Senior team members were once graduates like you when they started their careers. They are now RA experts eager to share their expertise with you.

Are you an enthusiastic graduate who wants to aim high in order to fulfil the unmet needs of patients? These are typical tasks you may engage in when starting your career with us:

  • Regulatory scientific writing of several parts (administrative, quality/CMC, non-clinical and/or clinical) of dossiers (such as clinical trial applications, scientific advice briefing books, orphan drug designations, pediatric investigation plans, marketing authorisation applications/variations) in line with regulatory requirements and scientific principles.

  • Interact with colleagues, internally as well as from our client companies, for the collection of information necessary for regulatory submissions and to address questions from health authorities.

  • Contribute to defining a sound regulatory scientific strategy for development and life cycle management of medicinal products.

  • Contribute to regulatory affairs project planning and coordination for timely submission of regulatory documentation and responses to questions from health authorities in the EU and Benelux, respecting procedural timetables and deadlines.

  • Support the maintenance of product information (labelling) in line with company core data sheets and regulatory requirements at EU and/or Benelux level.

  • Contribute to the maintenance of quality systems and SOP writing.

In a nutshell, every day you will learn and evolve towards a deeper mastery of Regulatory Affairs.

Your background, strengths and mindset

  • Bachelor, Master or PhD in a scientific discipline relevant to the development of medicinal products (e.g. pharmaceutical or biomedical sciences, (bio)chemistry, bio-engineer, other).

  • Keen interest in pharmaceutical regulations and drug development. Scientific background in the specialized areas such as biologicals, vaccines, infectious diseases, oncology, immunology is a plus.

  • Exposure to or initial experience with regulatory affairs and elements of drug regulation is an asset.

  • Proficient oral and written English and Dutch language skills; French and German is a plus.

  • Very good writing skills in English and passionate about analyzing scientific information and presenting scientific data in an accurate and clear way.

  • Positive and pleasant personality with effective interpersonal and communication skills to build and maintain relationships with internal and external stakeholders (such as RA colleagues, client project teams, competent authorities).

  • Diligent to work in compliance with regulatory legislation and Quality Assurance systems.

  • A dynamic person and good team player who can adapt to different settings,

  • A fast learner who is accurate, proactive, reliable, hands-on, and quality output driven.

  • Able to work against deadlines and set priorities.

Our offer

  • While interacting constantly with major pharmaceutical and biotech companies, you are part of a young, diverse and dynamic team with 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 by regulatory affairs.

  • A clear commitment to invest in expanding your knowledge and personal growth. 

Working conditions

The PhaRA office is located in Antwerp, Belgium. Excellent accessibility by public transport (literally 5 minutes’ walk from Antwerp Central Station).

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, especially for junior people. Of course, respecting all necessary precautions and government instructions comes first.

Normally, your job requires regular commutes to clients and/or partially working from a client’s premise.

Job application