Regulatory Affairs Professional
Vor 4 Tagen
We are seeking a highly skilled Regulatory Affairs Professional to join our team at Lonza. As a key member of our regulatory affairs team, you will play a critical role in ensuring the compliance of our biologics products with global regulatory requirements.
Key Responsibilities:- Author and review Module 3.2 dossier sections for customer filings, including IND/IMPD, BLA/MAA, and life cycle variations submissions.
- Lead and coordinate submission-related activities to ensure timely delivery of regulatory documents in accordance with Lonza procedures and good practices.
- Act as the primary point of contact for assigned projects and provide regulatory support to internal project teams.
- Track and negotiate source document availability required for clinical and commercial submissions.
- Prepare and review responses to health authority submission review questions (RtQs) and briefing documents for scientific advice meetings.
- Attend customer meetings and provide regulatory advice for assigned projects.
- A Master's degree in Biology, Chemistry, Biochemistry, Pharmacy, or equivalent, with a preference for higher education (PhD, PharmD) or Regulatory Affairs Certification (RAC).
- At least 5 years of experience in preparing and authoring M.3.2 CMC dossier sections for DS, DP, and Appendices through the product life-cycle.
- Ability to work autonomously and in a team environment.
- Previous experience in a CMO/CDMO environment is a significant advantage.
- Exceptional communication and interpersonal skills, with the ability to interact with internal and external customers regularly in a global environment across time zones.
- Experience in leading project teams to successful filings and approvals.
- Demonstrated skills in managing project timelines and priorities.
- A competitive salary of $120,000-$150,000 per year, depending on experience.
- Hybrid work conditions that offer a balance between remote work and collaboration in the office.
- The opportunity to work on complex projects that have a positive impact on millions of people worldwide.
- A collaborative and dynamic work environment that values creativity and innovation.
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