1) Direct day to day regulatory affairs activities, including reviewing promotional materials, participating in submissions to and interaction with regulatory agencies and providing regulatory support to all relevant functional areas
2) Contribute to formulation and execution of regulatory affairs strategy pertaining to all relevant company goals and objectives
3) Direct domestic and global regulatory projects, determine submission requirements, plan submission process and work with cross functional team to coordinate and approve regulatory documentation for inclusion in US and global regulatory submissions
4) Perform regulatory review of manufacturing, quality, research and commercial documents when appropriate
6) Provide facilitative commentary and feedback and assume responsibility for regulatory approval for relevant documents
5) Consult with and manage external regulatory affairs consultants
6) Monitor trends and changes in regulations and advise internal stakeholders on the potential impact to current and future strategy and tactics
7) Work with internal stakeholders to ensure that all relevant company activities are in conformance and compliance with regulatory law and guidance
8) Represent Regulatory Affairs on project teams to communicate the necessary regulatory requirements and facilitate the fulfillment of these requirements
9) Perform other responsibilities as assigned
1) University Degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (No students or fresh graduates please)
3) Recent experience in the Biopharmaceutical industry is strongly preferred.
4) Preference will be given to people have recent experience in Regulatory Affairs
The Life Sciences practice of Sterling-Hoffman was formed with a simple purpose:
help biotechnology, pharmaceutical & medical device...