What are the responsibilities and job description for the Senior Manager, Regulatory Affairs position at Alkermes?
The Senior Manager, Regulatory Operations will report to the Executive Director of Regulatory Operations and will be responsible for submission management across the development pipeline and support the commercial portfolio. The position will collaborate and interface with Regulatory Affairs, cross-functional teams, and related vendors to provide regulatory submission support, expertise, and overall technical guidance. The Senior Manager, Regulatory Operations will also assist with regulatory affairs systems, applications, and tools including supporting system implementations, maintenance, updates, and releases.
Responsibilities:
- Collaborate with Regulatory Affairs and cross-functional teams to plan for global health authority submissions, including overall timelines and deliverables.
- Manage and communicate with submission vendor on timelines and document hand-offs.
- Lead and support all regulatory submission types and ensuring they are compiled accurately and within specified timelines while maintaining high quality.
- Support the implementation of regulatory systems and tools, including migration and testing.
- Managing all document and submission types to be uploaded, maintained, and archived.
- Provide technical expertise to Regulatory Affairs and cross-functional teams as needed.
- Partnering with IT to maintain the regulatory technology landscape including maintenance, updates, and releases.
- Training of cross functional team members on submission processes to ensure compliance of standard operating procedures and health authority guidance and requirements.
Basic Qualifications:
- At least 10 years of related experience, with at least 5-7 years of direct experience in Regulatory Operations
Preferred Qualifications:
- Knowledge of IT systems and electronic submission requirements and processes.
- Detail oriented with exceptional organizational skills.
- Very strong PC / technical skills.
- Strong troubleshooting skills.
- Able to accomplish work independently and as part of a team.
- Able to set and meet deadlines but flexible with changing timelines.
- Determine task priority and ensure deadlines are met.
- Team player as demonstrated by good communication and collaboration skills.
- Strong interpersonal skills, including the ability to remain calm, professional, and positive.
- Exercise confidentiality.
