Senior Regulatory Affairs Specialist

1w1 week ago

Innovaderm Research Inc.

DE · Full-time · €70,000 – €95,000

About this role

The Senior Regulatory Affairs Specialist provides leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials. Oversees global/multinational complex large clinical trial submissions. Responsible for sponsor-facing regulatory leadership and management of regulatory deliverables within a country, region or globally.

Coordinates regulatory timelines and deadlines for RA and EC submissions across assigned projects. Prepares and reviews core and country packages for submissions to ensure compliance. Performs regulatory review of essential documents and authorizes release prior to investigational product shipment.

Supports the Associate Director Regulatory Affairs in special projects, process improvement initiatives, training of new employees, and company initiatives. Acts as a mentor to new or junior colleagues within the regulatory team. Participates in kick-off meetings, client audits, and other project-related meetings.

Work with brilliant and driven colleagues in a stimulating environment valuing collaboration, innovation, reliability, and responsiveness. Eligible for flexible work schedule, ongoing learning and development, and home-based position. Offers attractive advancement opportunities in pharmaceutical research.

Requirements

Bachelors' degree (or equivalent) in a scientific discipline; Regulatory Affairs is an asset
3-5 years in clinical regulatory affairs in the pharmaceutical, biotechnology and/or CRO industry
Experience preparing and submitting IRB/IEC packages and/or Clinical Trial Applications
Strong understanding of global regulatory requirements and guidelines in assigned countries/regions
Experience in global leadership role with focus on regulatory regions such as Europe and APAC
Experience of the regulatory process under EU-CTR
Fluency in English with excellent oral and written skills
Good knowledge of good clinical practices, Health Canada, FDA, and Regulation (EU) No 536/2014

Responsibilities

Coordinates regulatory timelines and deadlines for all assigned projects planned for RA and EC submissions
Leads global/multinational submissions of complex large clinical trials
Addresses sponsor queries related to regulatory and submission requirements
Provides regulatory support and advice to project teams with project-specific local submission strategy
Prepares/reviews core packages and country packages for submission to RA in assigned countries
Develops/reviews Country ICFs and country-specific labelling content for clinical trial drug supplies
Performs regulatory review of essential documents and authorizes regulatory release prior to investigational product shipment
Acts as a mentor to new or junior colleagues within regulatory team