Senior Regulatory Affairs Specialist

About the Company:

Founded in 1966, Lotus (1795: TT) is international pharmaceutical company with global presence, focused on commercializing novel and generic pharmaceuticals, offering patients better, safe and more accessible medicines. The Company has a recognized best-in-class R&D and manufacturing platform in Asia and has established partnerships in nearly every global market including the U.S., Europe, Japan, China, and Brazil. Lotus runs over 100 strategically selected pharmaceutical projects in development and registrations across Asia and the US, with over 250 commercial products. The Company invests in diversified best portfolio consisting of high-barrier oncology, complex generics as well as 505(b)2 and NCE via internal R&D investment and licensing-in partnership, and also strengthens its portfolio competitiveness by adding biosimilar products with support from strategic partners. Its industry-leading infrastructure certified by most of the advanced regulatory authorities around the world, including US FDA, EU EMA, Japan PMDA, China FDA, and Brazil ANVISA.

About the Role:

This is full time, permanent position, you will responsible for Licensing-in products of maintenance across APAC region.

Responsibilities:

• Initiation, coordination and tracking of variations for the assigned medicinal products from the company portfolio, approved through national procedures in APAC or EU and through DCP, MRP
• Coordination of variations or other activitites after the MA was obtained, taking into consdieration the impact on product launch or replenishement orders which might be affected
• Monitoring and taking the necessary actions to ensure that all the commitments to MA are fulfilled on time
• Coordination and tracking of renewals for the assigned medicinal products from the company portfolio, approved through national procedures in APAC or EU and through DCP, MRP
• Ensuring that all the additional processes related to national submissions (DMF, PMF, GMP accreditation etc.) are maintained and renewed on time and that their submission/approval process does not affect the MA validity
• Ensuring that all responses to authorities' requests are correct, complete and timely submitted, including the responses to LoDs for the allocated projects as well as the ones related to PI for all the ongoing procedures
• Collaboration with the Pharmacovigilance Department for streamlining the processes with impact on PI and safety variations
• Provide support for documents and samples preparation for tenders and legal activities related to patents
• Ensuring that complete and correct documentation is received, so that responses are sent to the authorities' requests, wihtin the deadline imposed by that specific authority/legislation in place
• Collaborating with colleagues from the same department or other departments (e.g. Supply Chain, Business Development, Pharmacovigilance, Marketing, Intelligence Property etc), and establishing the best strategy for all aspects in relation to MA maintenance
• Informing all involved departments on the status and progress of the assigned projects, so that objectives are met, any potential issue is identified and solutions are being found
• Keeping up-to-date the dabatase as well as relevant trackers
• Keeping up-to-date with the current legislation within the area of responsibility

Qualifications:

• Education: University degree in Pharmacy, Chemistry, Biology, Biochemistry, Medicine, Life Sciences
• Work Experience: At least 3 years experience in Global Regulatory Affairs

Required Skills:

• English language: advanced level, both speaking and writing; good understanding of English medical terms and CMC documentation
• Ability to prioritize own workload to meet deadlines
• Results and detail-oriented approach to work delivery and output
• Enthusiastic, proactive, self-driven, and willing to take over new responsibilities
• Team player
• Strong communication, interpersonal, and organizational skills
• Problem solving skills
• Computer skills: very good knowledge of MS Office tools