As Regulatory Affairs Manager (RAM), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.
You will be dedicated resource to one of our clients, be embedded in their working environment, systems and processes. You will be engaged in a wide range of interesting and challenging tasks.
You will be partnering with one of the worlds premier Biopharmaceutical companies. Working across a vast portfolio of medicines and vaccines this company has, over centuries created a strong heritage of delivering innovative treatments and preventive medicines globally.
What you will be doing:
- Project manages submission related operational aspects. Creates and manages project plans for regulatory projects using input from key stakeholders. Leads and manages cross functional submission teams from authoring to dispatch/project goal delivery. Identifies operational risks with projects/submissions, implements mitigation plans, and manages issues to closure.
- Represents the regulatory project and submission management (RPSM)
group in cross-functional planning to develop global regulatory submission and execution plans in line with the client’s needs and regulatory team goals.
- Partners with document providers to project manage the timely receipt of submission ready documents for inclusion in local/regional/global dossiers.
- Communicates external agency submission standards and internal business submission processes to ensure compliance and efficiency in the delivery of submission.
- Ensures that company is aware and responsive to external guidelines, regulations, changes in the marketplace and other information relating to local/regional/general regulatory project and submission management.
What you need:
- Undergraduate degree or international equivalent in clinical, science, or healthrelated field from an accredited institution; health care professional licensure, i.e., Pharmacy, Life Sciences, Business or In