Contract length: 1 year, may be extended
Schedule: Flexible days, part time (24-32 hours/week)
REMOTE
Requirements
Soft skills:
Strong attention to detail and organizational skills.
Excellent written and verbal communication skills.
Proficiency with publishing and submission software and tools.
Ability to manage multiple projects and meet deadlines in a fast-paced environment.
Hard/technical skills
Proficiency with industry standard publishing and submission software and tools (Microsoft Word, Acrobat Pro, ISI Toolbox, US Health Authority portals)
Ability to navigate standard business applications (Gmail, Chat, DMS, Veeva RIMS, and other business applications).
Minimum years of experience: 5 years
Education requirements: BA, or equivalent professional experience
Job Title: Regulatory Submission Publishing Specialist Life Sciences
Overview:
We are seeking a Regulatory Submission Publishing Specialist to join our Diagnostics
Regulatory Affairs team. The ideal candidate will manage and facilitate the preparation,
submission, and publishing process of regulatory submissions intended for registration
purposes, primarily in the US or EU.
Key Responsibilities:
Coordinate the submission and publishing process for regulatory registrations,
primarily for the US and EU markets.
Prepare submissions in accordance with external health authority guidelines, and
internal standard practices.
Prepare and format documents according to publication and submission
requirements.
Liaise with project leads, project teams, and regulatory bodies to gather
necessary documents and ensure smooth submission processes.
Maintain tracking systems to monitor the status and deadlines of all submissions.
Support the management of publication databases and repositories.
Collaborate with Regulatory Leads and Managers to ensure submission
deliverables meet requirements are fulfilled.
Qualifications:
BA in Life Sciences, Regulatory Science, Quality, or related field.
Proven experience in preparing compliant regulatory submissions in the
diagnostics or pharmaceutical sector.
Strong attention to detail and organizational skills.
Excellent written and verbal communication skills.
Proficiency with industry-standard publishing and submission software and tools.
Ability to manage multiple projects and meet deadlines in a fast-paced
environment.
Familiarity with regulatory guidelines such as FDA, EMA, ICH, GxP, and
publication ethics.
Preferred:
Proficiency with industry standard publishing and submission software and tools
(Microsoft Word, Acrobat Pro, ISI Toolbox, Veeva RIMS, US Health Authority
portals)
Previous experience in a diagnostics, pharmaceutical, or biotech company.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.