Sr. Manager, Regulatory Operations Management- Contract - New Jersey
Proclinical is seeking a dedicated and detail-oriented individual for the role of Sr. Manager, Regulatory Operations and Submission Management. This remote contract position will lead regulatory operations activities and manage US and global submissions for the Regulatory CMC group.
Primary Responsibilities:
The successful candidate will ensure the creation of high-quality regulatory submissions packages that align with health authority requirements and are consistent with internal templates and style guides.
Skills & Requirements:
- Proficiency in pre-publishing for regulatory submissions.
- Experience in biologics programs. Knowledge of antibody drug conjugates is a plus.
- Advanced proficiency in MS Office applications.
- Strong knowledge of best industry practices for eCTD publishing and eCTD viewer programs/solutions.
- Proficiency using Adobe Acrobat Professional.
- Knowledge of US FDA regulatory requirements.
- Excellent organizational skills.
- Ability to manage a fluid workload with tight timelines.
- Strong communication skills.
- Strong project management skills.
- Attention to detail with an ability to perform critical review of various types of documents.
- Ability to independently solve problems and facilitate resolution of issues.
- Demonstrated ability to work as a team player with multi-disciplinary project teams.
The Sr. Manager, Regulatory Operations Management responsibilities will be:
- Lead regulatory operations activities and manage US and global submissions.
- Ensure creation of high-quality regulatory submissions packages.
- Provide pre-publishing (technical editing and document formatting) for regulatory submissions.
- Author, review, and approve regulatory submissions in collaboration with Regulatory strategist and cross-functional SME team.
- Interface with multiple external publishing vendors to plan and manage submission activities.
- Maintain archives of regulatory submissions and correspondence.
- Maintain templates and style guides.
- Identify process improvement opportunities and drive solutions
If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at b.forsen@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
