Sr manager, regulatory and IP management

The regulatory and IP management Sr manager oversees regulatory submissions in compliance with regulations as well as the guidelines set by regulatory bodies. He/she also in charge of designing and implementing the Company's patent strategy in Europe and Taiwan.

Key missions

Regulatory Affairs
Contribute to Onward’s strategic plan and annual plans regarding registration matters;
Review draft regulatory files in Europe and Taiwan and submit new and amended regulatory applications;
Provide input as required, for example on technical matters, for investigational medicinal product dossier (IMPD/IND);
Ensure that quality standards are met, and all submissions meet agreed deadlines;
Manage complaint documentation;
Interact with health authorities in Europe and Asia;
Improve internal processes to reduce risk;
Write and periodically update drug regulatory affairs (DRA) related local SOPs;
Prepare and participate in presentations on regulatory affairs matters, and provide advice to Onward’s translational Science and Clinical teams

IP
Contribute to Company’s IP strategy and build IP roadmap.
Perform IP due diligence related to internal products and programs and in support of business development transactions;
Design, propose, and implement creative solutions to IP-related issues that may arise;
Work with Onward’s scientists and R&D project leads to flesh out inventions, prepare invention disclosures, plan IP enabling studies in support of patent filings and vet new technologies for Freedom To Operate (FTO);
Work with external IP experts in preparing and prosecuting worldwide patent applications;
Ensure timely and accurate documentation and maintenance of the patent portfolio;
Stay updated with relevant laws, regulations, and industry trends in IP;
Conduct legal research on key questions and providing written reports;
Responsible for maintaining existing trademarks and preparing new applications if deemed necessary.

Profile
A Diploma or master law degree from an accredited institution;
Bachelor’s degree in pharmacy and advanced degree (MSc., PhD) in cell biology, immunology, pharmacology, biochemistry, or similar field;
Relevant experience in Patents/ Intellectual Property law within biotech / pharma sectors in Asia and Europe;
Experienced in reviewing, drafting, and prosecuting patent applications and performing freedom to operate assessments;
Solid understanding of the drug development process, pharmaceutical legislation and scientific matters;
·       Specific experience in early-stage development, filing of NDA / BLA;
·       Experience in working with health authorities in Taiwan and/or Europe;
Excellent oral and written communication skills;
Ability to communicate scientific information in a clear and concise manner;
Ability to work collaboratively in a fast-paced, interdisciplinary team;
·       Fluent English and Chinese;
French B2 level minimum.

About Onward Therapeutics

We are a development stage oncology company, focusing on the identification of innovative technologies and the development of truly breakthrough medicines for the treatment of cancer. Our company, led by an experienced team in translational science and drug development, acquires licenses for potential development candidates and invest in partners with transformative technology platforms. We are located at Biopôle, a life sciences campus in Epalinges near Lausanne, Switzerland, we have an affiliate in Paris, France, and also operate from Taipei, Taiwan.

Please send your application to :

recruitment@onward-therapeutics.com