Manager, Regulatory Affairs International
Aegerion Pharmaceuticals is a biopharmaceutical company dedicated to the development and commercialization of innovative, life-altering therapies for patients with debilitating, often fatal, rare diseases.
At Aegerion, we believe that our employees are our strongest asset. We strive to recruit high performing, best-in-class candidates who possess a proven track record of success. We seek candidates who are patient-centric, passionate, entrepreneurial-minded, and interested in joining a high caliber and collaborative team. Our culture offers a kind, energetic, high-growth, and fun environment that provides an unmatched opportunity for individual contribution and development. We emphasize the ability to make an indelible differencewithin the organization and in the lives of our patients. Aegerion’s headquarters are in Cambridge, MA, and the company trades on the NASDAQ Stock Exchange under the ticker: AEGR. For more information about Aegerion, please visit www.aegerion.com.
Manages, evaluates and completes international regulatory projects consistent with the company goals. Responsible for timely planning, coordination and submission of regulatory dossiers in non-US, non-EU regions (e.g., LATAM, APAC). Provides guidance to cross-functional teams on regulatory strategy and regional regulatory requirements.
- With minimal supervision, plan and manage regulatory activities related to assigned projects in non-US, non-EU regions as directed;
- Assist in developing and implementing strategies for the earliest possible approvals of regulatory submissions associated with assigned projects;
- Manage the assembly and timely submission of regulatory dossiers as required for clinical trials and registration of products in non-US, non-EU regions as directed;
- Serve as liaison with country managers and local regulatory consultants on regulatory matters;
- Prepare Requests for Proposal (RFPs) and help identify and select local regulatory consultants;
- Participate on project teams and provide expertise on international regulatory matters;
- Develop and maintain current regulatory knowledge in countries/regions of interest and advise management of significant developments;
- Review technical documentation and recommend/implement changes as appropriate to ensure regulatory compliance and conformances to existing regulatory approvals in ICH regions (e.g., life-cycle management).
Qualifications and Experience
- Bachelor's degree or higher
- 6-8 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry
- Experience in orphan drugs desired
- Experience in preparation and submission of a full submission or large variation/supplement in at least one International region (e.g., LATAM, APAC) through to authorization
- Working knowledge of international (e.g., LATAM and APAC) regulations related to clinical trials and marketing applications in at least one International region; understanding of Competent Authority structure and function
- Experience with managing regional consultants
- Must have eCTD experience
- Proficiency with Microsoft Word desired
- Outstanding written and English verbal communication skills, Spanish written and verbal communication skills desired
- Outstanding interpersonal skills
Qualified candidates are encouraged to submit a resume and cover letter to Human Resources in care of email@example.com
No phone calls please. Resumes from third party vendors will not be accepted.