Job Description

Regulatory Affairs Drug Development Specialist (Pharma/Biotech) Remote

San Diego, CA (Remote)

$60-75hr Based on experience (Weekly pay + Benefits)

6–12-month contract (Excellent potential for permanent)

Full-time: M-F 8am-5pm (attend meetings PST as needed)

**Please note: Must have 4-12 yrs working in Regulatory Industry as a Regulatory Specialist; must be only within Pharma, Scientific, or Biotech Some exposure to drug development. (IND, NDA, BLA)

Our client recognizes that their exceptional employees are vital to our success. They are a dedicated team focused on meeting the unique needs of rare patients. Their work is rewarding – both professionally and personally – because they are making a difference. The team is seeking talented individuals who will thrive in their collaborative, diverse, fast-paced environment and share in their mission – to identify, develop and deliver life-changing therapies to people living with rare disease. They are pursuing of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease!

Position Summary:

This role is responsible for assisting with labeling development and Regulatory advertising and promotion. As a member of the Commercial Regulatory Team, this person works closely with internal stakeholders to ensure that labeling and advertising/promotional activities are aligned with both internal strategies and regulatory guidance. This position represents Regulatory Affairs on key review committees and assures compliance with all market commitments and global regulatory standards.

Responsibilities :

• Assist cross-functional teams in development of target product profile, core data sheet, and regional labels.
• Review and approval of US promotional materials for assigned assets.
• Provide promotional regulatory input on concepts and draft materials to help ensure promotional materials are consistent with regulatory guidelines and support business objectives.
• Collaborate to achieve team, department, and corporate goals across programs.
• Liaise effectively with Regulatory Affairs counterparts to ensure aligned representation and decision making.
• Ensure effective and professional relationships with internal teams, external scientific and business partners, regulatory experts, and health authorities.
• Ensure applicable regulatory requirements are considered and appropriately incorporated into all programs, ensuring compliance with appropriate regulations and guidelines.
• Assist in Regulatory Intelligence in research and analyze regulatory information and maintain current regulatory knowledge.
• Identify gaps and challenges and propose options to address them.
• Apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts, and draw valid conclusions.

Requirements:

• Bachelor’s degree or applicable job experience
• 4-12 yrs working in Regulatory Industry; must be only within Pharma, Scientific, or Biotech
• Some exposure to drug development. (IND, NDA, BLA)
• Navigate regulations and advertising/promotions, as well as regulatory challenges.
• Experience in labeling and ad promo helpful
• Knowledge of pharmaceutical/bio-tech drug development and regulations pertaining to labeling
• Bonus: Prescription drug labeling and research
• Bonus: Knowledge of OPDP ( Office of Prescription Drug Promotion)
• Bonus: Experience in Advertising promotions; taking labels and adding promotional materials; marketing exposure or interested in learning
• Ability to provide promotional regulatory input on concepts and draft materials to help ensure promotional materials are consistent with regulatory guidelines and support business objectives.
• Experience with US labeling requirements and guidance.
• Experience to work closely with internal stakeholders to ensure that labeling and advertising/promotional activities are aligned
• Experience with understand implications of label changes on pending and approved labels.
• Must have excellent attention to detail for this role
• Requires experience working independently and remotely
• This position requires academic scientific training, analytical skills, and keen attention to detail.
• Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment
• Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complex projects and interdependent timelines.
• Ability to adapt to evolving project timelines and goals, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.

Please send your resume,

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