Regulatory Affairs Manager

The BioInvent team covers all aspects of drug development, including discovery, preclinical and translational research, manufacturing, and clinical development.

Regulatory Affairs Manager

As our Regulatory Affairs Manager, you will plan, author and manage the assembly and timely submission of regulatory documentation for EU, US and RoW. The role will provide strong support and guidance to cross-functional teams (across multiple projects) and CROs.

The main responsibilities are as follows:

Regulatory Affairs Manager at BioInvent is responsible for operational regulatory work executing global regulatory strategies aimed at identifying and implementing the most efficient regulatory pathways for BioInvent’s current and future drug development programs.

The responsibilities of the position include, but are not limited to:

• Responsible for coordination, development, authoring and reviews of high-quality regulatory documentation for various types of regulatory submissions (e.g., core documents for IND/CTA, incl. substantial amendments/modifications, scientific advice packages, orphan drug designation applications etc.)

• Coordinate preparation of responses to Health Authority requests for information

• Work with internal cross-functional project teams and CROs to ensure timely deliverables to regulatory strategies for any company project goals

• Oversight of CROs regarding CTR increased notification requirements and documentation redaction

• Ensure maintenance of regulatory compliance, conformance of internal quality procedures and provide training to internal stakeholders with guidance on impact of new regulatory and scientific regulations

• Support quality, regulatory, clinical and other personnel in the company as required regarding current regulatory policies and procedures.

• Take on specific tasks as a representative of the Regulatory team, in line with your individual capabilities and interests.

• Performing all duties in keeping with BioInvent’s core values, policies, and all applicable regulations.

Requirements

· At least 5 years experience in regulatory affairs in the biotech or pharmaceutical industry, with broad cross-functional regulatory knowledge in addition to special competence/interest within clinical regulatory documentation.

· Working knowledge of Regulatory legislation, worldwide, and standard documentation/ document types including understanding of GDP.

· Highly organized, proactive, and detail oriented

· Experienced communicator and facilitator

· Enjoy creating and participating in an efficient cross functional working environment

· Effective time manager

· Good organization and problem-solving skills

· Proficient in MS Word, Excel, Power Point, Outlook

· Good technical writing and editing skills

· Proficient in written and spoken English

Qualifications

· Educated to MSc level in a relevant science discipline.

· Regulatory affairs experience including assisting in the developing regulatory submission documents and coordinating delivery to submission plans, usually demonstrated by 5+ year exposure

Reporting to: Senior VP Regulatory Affairs

Personal Profile

We are looking for a driven, structured, self-motivated and responsible person, who easily collaborates and communicates with others both verbally and in writing. You have excellent problem solving, and negotiation skills and you enjoy creating efficient working methods and contributing with your experience to ensure continuous improvements.

Personal suitability is of great importance, and we believe that you are efficient, have a strong commitment and ability to make things happen. You understand the importance of achieving results, keeping deadlines and to secure high quality within your work. You are enthusiastic and enjoy creating results and achieving goals both individually and together with your teams.

Location

The position offers a flexible working arrangement.

Application

Please send your application (CV and personal letter) and tell us why you are the right person for this position. Please make sure to send in your application as soon as possible, at the latest 20th of August 2024.