In-house Senior RA Specialist

PharmaRelations Aps

Denmark - København

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PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialize in partnering with some of the top and most innovative organizations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders.

We are a Nordic organization with over 270 colleagues and with offices in Sweden, Norway, Denmark and Finland. Our headquarter is located in Solna, Sweden.

We are expanding the Danish Regulatory Affairs team with a new in-house Senior RA Specialist.

About the Role
As a Senior RA Specialist at PharmaRelations, you will be part of the Nordic in-house Regulatory Affairs function with employees in Denmark, Sweden, Norway and Finland, delivering regulatory ad hoc consultancy services to our clients. You will work with a range of life science companies from startups to global organizations, supporting a variety of tasks within Regulatory Affairs. Your contributions will be essential in helping clients drive their regulatory strategies from the early stages of drug development and as they progress their clinical pipeline, as well as supporting product approvals and ensuring regulatory compliance in the post-approval stages.

This role offers you a unique opportunity to develop your expertise as a Regulatory Affairs Specialist while having a significant impact on client success.

The position is a permanent employment with PharmaRelations, and you will be working on assignments primarily from our office in Virum, but also at client’s sites when relevant.

Key Responsibilities
You will be responsible for solving a variety of tasks aiming at ensuring regulatory compliance at all stages of the life cycle of a pharmaceutical product, and you provide high-quality services and deliverables to our clients.

Key tasks will depend on client needs, and comprises:

• Preparing and executing global regulatory strategies, with a focus on EU and US
• Being responsible for the client’s contacts with regulatory authorities
• Acting as the Regulatory Affairs representative in cross-functional project teams
• Being a sparring partner for the client on Regulatory Affairs topics and issues and
• Preparing and coordinating documentation for regulatory submissions
• Evaluating compliance tasks, reviewing and approving marketing materials
• Supporting clients with hands-on ad hoc tasks, as needed

Qualifications
To succeed in this role, you must have a solid understanding of Regulatory Affairs tasks and issues throughout the entire pharmaceutical value chain. You understand the client’s perspective and can guide clients based on your knowledge about what is “need-to-have” and what is feasible. It is a must to have experience with the regulatory frameworks in both EU and US.

Key qualifications include:

• A university degree in life sciences, preferably M.Sc. in Pharmacy or similar
• Minimum 8 years of experience in a variety of Regulatory Affairs roles in the pharmaceutical industry
• Minimum 3 years of experience with preparing and executing global regulatory strategies and drug development activities within US and EU
• Ability and willingness to engage with clients
• Desire for and capabilities to work with a wide range of tasks at different levels of complexity and within different set-ups
• Strong communicative skills, verbally as well as written, both in Danish and English
• A positive can-do attitude, and the ability to work independently as well as in a collaborative team environment

The preferred candidate has experience from a variety of company types, i.e. headquarter, affiliate, biotech etc, and experience with working as a consultant is a strong plus.

Why PharmaRelations?
At PharmaRelations, we believe in creating an inspiring and supportive work environment that promotes both personal and professional growth. As a Senior RA Consultant, you will:

• Work on exciting and varied projects across different pharmaceutical companies
• Have the opportunity for continuous learning and career development
• Enjoy a flexible and supportive working environment with a focus on work-life balance
• Be part of a small local team and a cross-Nordic functional area, where collaboration, support, and teamwork are key

Apply Now!
If you are excited about working for the pharmaceutical industry in a consulting role, thereby making a real impact on drug product development and regulatory compliance, we would love to hear from you. Due to GDPR we cannot accept applications via email, please apply via our website.

If you have any questions please contact Margrethe Erbou Andersen, Head of Regulatory Affairs Denmark, [email protected] (+45 3590 1129) or Jens Knud Maarup, Recruitment Consultant, +45 5433 4320.

Applications will be handled continuously. We look forward to hearing from you!