Head of Regulatory Affairs Developent - Sweden

PharmaRelations is looking for a Head of Regulatory Affairs Development to lead and further develop our Regulatory Affairs services in the drug development space. This is a Sweden-based position, and you will be part of the Regulatory Management Team, reporting to the Nordic Head of Regulatory Affairs based in Denmark. This is a unique opportunity to combine deep regulatory affairs expertise with leadership, business development and client advisory work in a highly entrepreneurial environment. As Head of Regulatory Affairs Development, you will play a key role in shaping the future of our service offerings while supporting innovative biotech and pharmaceutical companies in bringing new medicines from development through regulatory approval. The role includes some travel within the Nordic countries. If you are not based within commuting distance of our Solna office, you should be comfortable travelling to the office a couple of times per month. About PharmaRelations PharmaRelations is the leading Nordic Life Science consulting partner, connecting expertise, talent and organizations across the pharmaceutical, biotech and medical technology industries. What many of us appreciate most about working at PharmaRelations is our entrepreneurial culture, short decision-making paths and the genuine opportunity to influence both the business and your own development. We believe in empowering our leaders to take initiative, challenge existing ways of working and contribute to the continued growth of the organization. This role offers a unique opportunity to shape and further develop our Regulatory Affairs Development offering, while building client relationships and driving commercial growth. The Role This is a multifaceted leadership role combining regulatory affairs expertise, strategic advisory work, customer engagement and business development. You will lead and further develop our Regulatory Affairs Development team while supporting clients with strategic regulatory affairs guidance throughout the drug development lifecycle. The role will include:

• Leading and developing the Regulatory Affairs Development team
• Supporting, coaching and developing regulatory affairs consultants
• Driving business development activities and building client relationships
• Identifying new consulting opportunities in the market
• Acting as a trusted strategic advisor to biotech and pharmaceutical clients
• Developing and executing global regulatory strategies for clients
• Providing strategic regulatory affairs leadership across drug development programs for clients
• Supporting interactions with health authorities including FDA and EMA for clients
• Helping shape and expand PharmaRelations' Regulatory Affairs Development service offerings

The role will initially combine leadership responsibilities with hands-on client work and consulting assignments. Your Background We are looking for a senior regulatory affairs professional with extensive experience in clinical stage Regulatory Affairs work and a strong understanding of the tasks and challenges in global drug development. You likely bring:

• A university degree in Life Sciences, Pharmacy, Medicine or a related field
• Extensive experience within Regulatory Affairs for clinical stage pharmaceutical products
• Experience with developing and executing global regulatory affairs strategies
• Strong knowledge about EU and US regulatory frameworks
• Hands-on experience with preparing, conducting and leading health authority interactions, primarily in the EU and the US
• Experience with CTA and IND submissions
• Experience supporting pharmaceutical products from a regulatory affairs perspective through clinical development phases to marketing authorisation
• Experience from biotech, pharmaceutical companies and most preferably regulatory consultancy environments
• Leadership experience, either through line management or leading expert teams
• Excellent communication and stakeholder management skills
• Fluent English communication skills

This is you To succeed in this role, we believe you combine scientific credibility with commercial awareness and strong leadership capabilities. You have a cross-functional mindset and understand how areas beyond your immediate regulatory scope, such as CMC and non-clinical development, connect to and influence the overall development and regulatory strategy. You also are:

• A strategic thinker who can translate complex regulations into practical business decisions
• A trusted advisor who enjoys working closely with clients
• A collaborative leader who develops and empowers others
• Entrepreneurial and motivated by growing a business
• Relationship-oriented and comfortable building networks internally and externally
• Commercially minded without compromising scientific integrity

Curious, proactive and driven by continuous improvement Why Join PharmaRelations? At PharmaRelations, you will have the opportunity to:

• Shape and develop a growing strategic business area
• Make a visible impact on the organization's future direction
• Lead and develop a highly specialized team
• Work with innovative biotech and pharmaceutical clients across the Nordic Life Science sector
• Combine leadership, consulting and business development in one role
• Be part of an entrepreneurial company with short decision-making paths
• Grow professionally and personally alongside the business

Your application If you have a strong background in Regulatory Affairs and drug development and if you are excited by the opportunity to combine your expertise with client engagement, leadership and business development, we are very interested in hearing from you. Please click Apply to submit your application. For further information about the role and the recruitment process, please contact Kristina Edholm at PharmaRelations (kristina.edholm@pharmarelations.se).