Experienced Regulatory Affairs and Medical Writing Specialist

The Regulatory Affairs and Medical Writing Specialist has the responsibility for regulatory strategies and operational work (planning, medical writing, managing the assembly and timely submissions of regulatory documentation) for BioArctic projects.

The role actively supports post-approval regulatory activities and contributes to updates and maintenance of BioArctic's internal systems and work routines to meet the regulatory requirements for a marketing company in the Nordic Countries.

Responsibilities

• Responsible for planning, coordination, development and authoring of submission of regulatory applications to regulatory authorities for BioArctic's investigational products (clinical trial/IND documentation, scientific advice briefing books such as pre-IND meeting, FDA Type C meeting, national and EMA scientific advice, PMDA consultation)
• Develops strategies for development projects in BioArctic portfolio, including identifying the possibilities for regulatory designations, e.g. Orphan designation, PRIME, Breakthrough designation etc.
• Provide regulatory oversight for clinical trials conducted by BioArctic, coordinate response to queries
• Responsible for planning, preparation of regulatory designations such as Orphan designation, PRIME, Breakthrough designation etc. for BioArctic projects
• Responsible for BioArctic's internal systems and work routines to meet the regulatory requirements for a marketing company in the Nordic countries
• Coordinate updates of the Nordic product information systems for Leqemebi as part of BioArctic's role as Local Representative in the Nordics
• Coordinate work with relevant consultants, and external partners and ensure consistency in communication
• Provide support to cross-functional teams related to activities for global regulatory compliance and improvements on internal procedures, provide with guidance and impact assessment of new regulations in relevant regions
• Act as point of contact with regulatory authorities
• Leverage both technical and regulatory knowledge, to mitigate risks and ensure documentation quality
• Investigate opportunities for regulatory innovation and promote the use of novel approaches within project team to resolve issues and problems
• Provide in house training of colleagues on regulatory-related matters as required

EDUCATION

University degree in a relevant natural science subject area.

Required Qualifications And Knowledge

• At least 10 years' experience of working with drug development, medical writing and regulatory affairs within the pharmaceutical and /or biotechnology industry
• Experience of development of biological products from research to late-stage development as well as post-approval activities
• Experience of authoring and preparing regulatory documentation for clinical trials (e.g. CTA, IND).
• Experience of authoring complex regulatory documents (e.g. Clinical Overviews and Briefing documents for regulatory authorities) and leading global cross-functional authoring teams.
• Experience of regulatory authority interactions and processes (EU, US).
• Deep level of knowledge of drug development
• Working knowledge of EMA, FDA and ICH regulatory guidance and regulations
• In-depth knowledge of medical writing, automatic text formatting, use of electronic document handling systems and SharePoint based tools
• Excellent communication and project management skills with ability to interact effectively with cross-functional project teams and regulatory authorities.
• Very good ability to communicate verbally and in writing.
• Fluency in English.

Meriting Qualifications And Knowledge

• Experience in CTD authoring and submission experience
• Experience of clinical development stages.
• Experience of projects for rare diseases and authoring of orphan designation requests (EU, US).
• Experience of accelerated approval pathways (EU and US).
• Experience of clinical development stages
• Experience of authoring pediatric development plans and waivers (EU, US)
• Clear track record of effective teamwork, collaboration, open communication and high engagement

Welcome with your application

Please note that the candidate selection is ongoing; applications may be closed earlier than the posted deadline.

For questions, please contact:

Olga Björklund, Senior Director Regulatory Affairs, for questions related to the position:

Mia Wadén, HR Business Partner, for questions related to the recruitment process:

BioArctic is an innovative Swedish biopharma company focusing on research into neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease and ALS. BioArctic's research has resulted in the world's first fully approved disease-modifying drug against Alzheimer's disease. The company has also developed the BrainTransporter technology, that has the possibility to improve the result of treatment against diseases of the brain. BioArctic's head office is located in Stockholm Sweden, and the company has more than 130 employees.