Senior Associate , Reg Affairs International
770 Lindaro St San Rafael, CA 94901
We are seeking a highly motivated, energetic professional capable of working effectively in a fast-paced environment to join our Regulatory Affairs International team. The Regulatory Affairs International Manager is responsible for supporting global regulatory activities for new product registration and life-cycle maintenance in Latin America, Asia Pacific, Eastern Europe/Asia Minor and Middle East/Africa.
- Understand regional laws, regulations, guidance, and global regulatory requirements while ensuring that elements, quality, accuracy and format of regulatory submissions comply with applicable laws and regulatory standards.
- In conjunction with regional leads and experts, manage project timeline, planning and preparation and submission of marketing applications, orphan drug applications and variations to support LATAM, APAC and EEAM/MEA regions. Must ensure all submissions are prepared in accordance with regional regulations.
- Participate on interdisciplinary regulatory teams in establishing global regulatory strategy
- Provide regulatory support to team members located in global offices.
- Manage the writing or updating of various sections of the MAs including the administrative, labeling, nonclinical, and clinical portions of MAs.
- Act as a main point of contact for specific projects and serve as an international regulatory representative on project sub-teams. The candidate will need a thorough understanding of commercial plans in order to provide insights on the feasibility for market entry.
- Participate in international health authority meetings, as required.
- Communicate with regulatory consultants regarding product development plans.
- Perform regulatory intelligence searches for registration and other regulatory requirements in applicable global regions.
- Flexible work schedule to maximize global interactions, as required.
- Up to 10% travel for regional business, health authority meetings, etc. may be expected.
- Minimum of 4-5 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the Regulatory environment. International regulatory experience preferred.
- Proven ability to manage critical projects as part of an interdisciplinary team. In addition, the candidate should have experience preparing, managing and submitting major regulatory submissions.
- Ability to successfully manage multiple projects to deadlines.
- Thorough understanding of relevant drug development and post-marketing regulations and guidelines and have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities.
- Skilled at gathering supportive information and developing product approval strategies.
- Proven track record of achieving regulatory goals in ambiguous and sometimes challenging situations.
- Rare disease experience is preferred
- International experience is preferred
- Bilingual/multilingual language skills are a plus
- Bachelor's degree in a science/life sciences.