Job Title: Regulatory Affairs Specialist Project Lead
Location: Remote
Duration: Long Term
Job Description
We are seeking a highly skilled Regulatory Affairs Specialist Project Lead I to join our remote team. This role requires an individual with strategic experience in medicinal products (small molecule or biologic) marketing applications such as NDA, BLA, and MAA. The ideal candidate will lead the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS) for immunology products in early development.
Key Responsibilities
Global Regulatory Strategy: Lead the development and implementation of comprehensive global regulatory strategies for immunology products in early development stages.
Health Authority Interaction: Develop and execute a global Health Authority (HA) interaction plan and strategy in collaboration with the Global Regulatory Team (GRT). Ensure effective communication of key outcomes to senior management.
Regulatory Submissions: Oversee the preparation, submission, and maintenance of regulatory filings (NDA, BLA, MAA) for medicinal products.
Cross-functional Collaboration: Work closely with cross-functional teams, including R&D, Clinical, and Commercial, to ensure alignment of regulatory strategies with business objectives.
Regulatory Intelligence: Monitor and interpret global regulatory trends and changes, providing strategic advice to internal stakeholders.
Risk Management: Identify potential regulatory risks and develop mitigation strategies to ensure successful product development and approval.
Required Experience And Qualifications
Bachelor’s degree (BS/BA) in a relevant scientific discipline is required.
Advanced degree (PharmD, PhD, MD, DVM, or MSc in Biology, Life Science, or related field) is preferred.
A minimum of 8-10 years of relevant experience in the pharmaceutical/biotechnology industry.
At least 5 years of experience in Regulatory Affairs, with a focus on early development stages and global regulatory strategies.
Proven experience with regulatory submissions for medicinal products (NDA, BLA, MAA).
Technical And Strategic Skills
Strong understanding of global regulatory requirements and guidelines.
Excellent project management skills with the ability to lead and motivate cross-functional teams.
Demonstrated strategic thinking and problem-solving abilities.
Ability to communicate complex regulatory issues to senior management and other stakeholders effectively.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Legal
Industries
Medical Equipment Manufacturing, Industrial Machinery Manufacturing, and Pharmaceutical Manufacturing
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