Senior Manager, Regulatory Sciences - Development
For the past 20 years, Pro
Pharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), Pro
Pharma partners with its clients through an
-
- operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, Pro
Pharma offers an
-
- end suite of fully customizable consulting solutions that
- risk and accelerate our partners’ most
- profile drug and device programs.
Responsibilities:
Independently leaddiscreet client projects (as assigned), and lead project teams through all project phases to ensure efficient project executionand contribute to larger projects.
As required, author global nonclinical/clinical aspects of regulatory documentation including environmental risk assessments, development plans, briefing books, orphan designations, paediatric investigation plans, marketing authorisation applications, contributing to gap analyses and regulatory strategies.
Project Management of assigned projects in accordance with internal procedures – including approval of time entry and invoicing, budget monitoring, client liaison and service growth.
Provide expert guidance and technical expertise, manage complex tasks and contribute to overall project strategy.
Lead interactions with clients and regulatory agencies on defined projects.
Build strong client relationships, manage client expectations and participate in client strategy discussions.
Support development of client budgets and business proposals.
Stay informed of relevant regulatory developments and contribute to regulatory/industry workshops, trainings and calls for collaboration .
Contribute to the ongoing improvement of internal regulatory processes and procedures.
Mentor and coach junior staff, line management if necessary.
Requirements:
Advanced degree (MSc/Ph
D) in a relevant field preferred.
Bachelor's degree in a life science field (e. g. , biology, pharmacy, pharmacology, toxicology) or a related discipline necessary.
8-10+ years’ experience within regulatory sciences for development products preferred
Expertise with nonclinical/clinical regulatory writing and advanced knowledge of nonclinical/clinical strategies for development products.
Experience of leading and delivering successful projects within budget and timeframe.
Experience managing client relationships within a consultancy setting preferred.
Demonstrated leadership and
- facing skills.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***Pro
Pharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.
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