Coordinate the creation and approval of global regulatory plans, and transmit to internal and external experts to execute the plan
Coordinate internal alignment and approval of global submission plans; ensure those plans can be executed with internal and external resources on time
Manage, track, review regulatory deliverables from external partners in line with vendor manager
Maintain regulatory work schedules with vendors and vendor managers for assigned project using common data-points and milestones
Coordinate GRS support for HA interactions lead by regional / local liaisons
Support Regulatory Lead in the preparation of HA interactions (meeting preparation, rehearsals, execution, follow-up, minutes, etc.)
Provide support for tracking progress and resolving issues with CTA preparations and submissions and approvals
Facilitate the regulatory dossier submissions to HA (IND, CTA, BLA, NDA, etc.) utilizing internal and external resources
Ensure appropriate quality controls in place for compliant submissions
Coordinate preparation of response to HA questions according to a rapid response process for assigned projects
Maintain tracking data in PMC and PMR database
Coordinate regulatory communications required for regulatory actions to regional and local regulatory
Writing, reviewing signing and submission of maintenance regulatory documents for all IND/CTAs - All within group with consultation of the USRL, EUL or GRL
Annual Reporting Responsibilities for regulatory owned components
Support submission of US BLA/NDA submissions
Solid scientific background (BS, MS, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine or veterinary).
Keen attention to detail (will be writing and reviewing documents)
1-3 years of pharmaceutical industry experience.
Oncology, cardiovascular, or immunology background preferred
Ideally 1 year in regulatory affairs or 2-3 years in a complementary functional area (eg, clinical research).
Working knowledge of regulatory procedures (US or other).
High-level of self-motivation and professional commitment.
Indirect management experience of people or major projects.
Ability to rapidly adapt to different issues and projects at one time.
Good interpersonal skills.
Excellent communication skills.
Comprehensive understanding of the pharmaceutical industry.
Comfortable working in a fast paced environment where speed is paramount.
Willing to work as a topic expert, outside of a traditional functional environment, in a team unified around serving the assets.
Ability to recognize, articulate, and accept calculated risks to make informed decisions.
Willingness and ability to effectively cooperate and partner with external vendors and the company.
Develop understanding of different TAs due to assignment to different projects.
Increased understanding of the regulatory procedures (US, EU, others) and regulatory landscape.
Increased exposure to global and multi-functional teams.
Potential development into Global Strategy function, US Liaison or other role in Regulatory Sciences.
Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional and geographic boundaries to achieve company goals.
Communicates opinions, facts and thoughts with clarity, transparency and honesty.
Demonstrates ownership of results within (and beyond) area of responsibility.
Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
Looks for opportunities for continuous improvement.
Synectics serves an extremely diverse client base which represents an equally diverse range of industries and institutions. The technologies we support have always been responsive to this extremely broad spectrum. In order to fully engage with this continually changing commercial and technological landscape, our employees must draw on their own varying interests, skills and backgrounds. This insight, reflected in our daily practices, has always been our fundamental strength as a company, and it continues to serve us well in all our efforts.