Senior Associate - Regulatory Affairs - Remote

Aptask Global Workforce (AGW) is seeking a Senior Associate - Regulatory Affairs for a Remote position with a Global Pharmaceutical Company. This is a 5+ month contract opportunity.

In this vital role, you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization. The position involves coordinating and executing US regulatory submissions in compliance with corporate standards and regulatory requirements, as well as managing the preparation, delivery, and electronic archiving of documentation.

Responsibilities:

• Assist US Regulatory Lead to support local regulatory activities (e.g. IND submissions and agency meetings)
• Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with US Regulatory Lead
• Create and maintain product regulatory information and history documents through company systems
• Appropriately archive regulatory documents and agency communications
• Collaborate with CROs / partners to support site initiation
• Complete regulatory forms to support agency communications
• Participate in GRT to support execution of regulatory strategy
• Coordinate QC of regulatory documentation (e.g. briefing materials)
• Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
• Assist in template development and maintenance
• Respond to specific requests from and communicate relevant issues to GRT
• Actively support regulatory compliance

Requirements:

• Master's degree
• Or Bachelor's degree and 2 years of Regulatory Affairs experience
• Or Associate's degree and 6 years of Regulatory Affairs experience
• Or High school diploma / GED and 8 years of Regulatory Affairs experience

Desired skills:

• Strong communication skills - both oral and written
• Ability to understand and communicate scientific/clinical information
• Ability to collaborate with team members to tackle problems and develop a course of action
• Cultural awareness and sensitivity to achieve global results
• Planning and organizing abilities
• Able to prioritize and balance multiple activities
• Ability to deal with ambiguity
• Ability to influence others
• Prior regulatory knowledge experience as a clinical strategist
• FDA experience is a bonus

Pay range: up to $34.76 per hour

Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position.

If you have the described qualifications and are interested in this exciting opportunity, apply today!

Aptask Global Workforce (AGW)

ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.

Benefits of working with ApTask Global Workforce include:

• Medical
• Dental
• Vision
• Sick Pay (for applicable states/municipalities)

Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website

ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.