Director, Global Regulatory Affairs, Early Development Therapeutic Area Lead, Development Products
Accountable to provide innovative, tactical and strategic regulatory leadership regarding maximizing the alignment between global regulatory strategies for development of drugs/new indications and regional regulatory strategies for the assigned development projects of the TA.
Provides global regulatory oversight for assigned therapeutic area(s), focused on pre-clinical and clinical aspects of drug development and associated regulations.
Provides direction to senior leadership and teams on emerging trends, regulations and changes, with emphasis on those related to therapeutic areas of responsibility enabling proactive approach and planning to future business requirements.
Provides senior leadership, mentorship and training within regulatory organization
Represent CSLB regulatory affairs strategic interests on key internal and external committees
Manages the regulatory affairs professionals in the team.
-Accountable for global regulatory development plans/strategies for all projects in TA scope (consolidated across JPN, US, EU and International)
Ensuring that requirements for clinical development programs for global product approval are communicated clearly.
In collaboration with Regional DP and International RA Liaisons, work to resolve regional critical conflicts in global regulatory strategies for development programs and oversee critical deliverables in alignment with commercial expectations.
Responsible to oversee and manage the GRLs regarding planning and execution of successful global regulatory strategies for assigned projects. Ensure they are complete, accurate and consistent with project objectives.
Requirements:
This includes:
•Advising on the need to seek external expertise
•Ensure global regulatory strategies are updated for stage gate evaluations
•Ensure global regulatory strategies are consolidated within GRA reflecting one voice
-Responsible to provide the strategic regulatory interface with Senior Scientific, Clinical R&D, Global Clinical Safety & Pharmacovigilance (GCSP), Project Management and Commercial Management. This includes fostering and maintaining a good relationship with internal stakeholders.
-Responsible to support the GRA Head Development Products in developing the Therapeutic Area Lead role, processes and regulatory infrastructure to support the function in successfully delivering expected results. Propose and develop/refine, implement and maintain global regulatory processes for the continued success of the function.
Presents and informs senior management on regulatory strategies and key issues.
Manages the resources, budgets, and ensures use of appropriate planning and tracking tools.
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Organizes, coordinates and manages the team to meet CSLs business needs:
•Builds productive team and drives their performance.
•Responsible for coaching and development of team members.
•Partners with Human Resources to select and onboard highly-qualified candidates (both internal and external) for open positions.
•Conducts annual performance evaluations for direct reports.
•Supervises and supports RA staff in the filing process.
Arranges for training and orientation of new regulatory affairs staff in accordance with CSLs global, regional
and local SOPs.
Ideal candidates will have a strong clinical foundation.
Experience and Requirements:
A Post graduate degree in pharmacy, biology, chemistry, pharmacology clinical medicine or related life science is required (MS, PhD or MD, DVM).
•Minimum of 15 years experience in the biotech or pharmaceutical industry, with at least 9 years in Regulatory Affairs
•Experience in leading and managing teams (Minimum 5 years), setting clear direction, holding people accountable and fostering a collaborative team environment.
•Candidates must have thorough knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in more than one key region (EU, US, Japan)
•Experience working in Regulatory Affairs in a global environment across two or more geographic areas (preferentially US and EU).
•Extensive experience interfacing with regulatory agencies and proven skill at developing and implementing successful global regulatory strategies.
•Experience working in a complex and matrix environment is required
•Demonstrated experience in working with multiple stakeholders.
