Sr Manager, Regulatory and Ip Management
vor 7 Monaten
**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;
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);
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;
**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;
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
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