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MSD este o companie biofarmaceutică globală care dezvoltă medicamente și vaccinuri pentru provocări majore din domeniul sănătății, inclusiv cancerul, bolile infecțioase, afecțiunile cardiovasculare și metabolice, precum și îngrijirea axată pe prevenție. Cunoscută sub numele Merck & Co., Inc. în Statele Unite, Canada și Puerto Rico, MSD îmbină cercetarea științifică cu expertiza în dezvoltare și comercializare pentru a oferi soluții de îngrijire a sănătății oamenilor și animalelor.
Activitatea sa acoperă domeniile Sănătății Umane, Sănătății Animalelor și Cercetării și Dezvoltării, creând oportunități pentru profesioniști din echipe științifice, clinice, comerciale, operaționale și corporative. Prin activitățile desfășurate în regiuni din întreaga lume, carierele la MSD reflectă accentul pus pe cercetare, colaborare, incluziune și progres responsabil în domeniul sănătății globale.
Associate Director, Oncology Regulatory Liaison
Lead regulatory strategy and agency engagement for oncology products at MSD. Support global registrations, lifecycle management, submissions, and compliant product development.
Descriere
- Support oncology products within a regulatory affairs team
- Partner with global regulatory leads on registration and product-maintenance strategies
- Contribute to marketing applications, IND submissions, pediatric plans, and annual or periodic reports
- Track, draft, coordinate, and review responses to regulatory agency requests
- Prepare agency background packages and marketing application documents
- Communicate with regulatory agencies and participate in agency meetings as needed
- Contribute to global regulatory teams and cross-functional meetings
- Evaluate regulatory guidance, precedents, and competitive intelligence
- Help prepare regulatory strategy documents
- Collaborate with Regulatory Operations, Clinical Safety, Labeling, Regulatory CMC, clinical research, and non-clinical safety teams
- Support quality compliance and lifecycle management for oncology programs
- Contribute to label development
- Support regulatory process improvement initiatives
- Handle regulatory administrative activities as needed
Cerințe
- Bachelor’s degree and at least 5 years of relevant pharmaceutical industry experience, or a master’s degree and at least 2 years of relevant experience, or an M.D., Ph.D., or related doctorate in biological science, chemistry, or a related discipline with relevant experience
- Experience with drug development
- Previous regulatory experience involving interaction with a major regulatory agency
- Excellent written and verbal communication skills
- Strong organization and the ability to manage varied activities across multiple projects simultaneously
- Flexibility
- Strong scientific and analytical capabilities with close attention to detail
- Oncology product experience is highly preferred
- Eligibility to reside in the United States and Puerto Rico
- Visa sponsorship is not available
- Willingness to travel up to 10%
- A valid driving license is not required
Beneficii
- Annual bonus
- Long-term incentive, where applicable
- Medical, dental, and vision coverage
- Additional insurance benefits for employees and families
- Retirement benefits, including a 401(k) plan
- Paid holidays
- Vacation leave
- Compassionate leave
- Sick leave
- Hybrid work arrangement
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