Regulatory Affairs Specialist

Manpower Engineering is partnering with a leader within the pharmaceutical industry for a Regulatory Affairs Specialist.


Job Title: Regulatory Affairs Specialist
Location: Minnetonka, MN (HYBRID)
Pay: $70 - $82/hour
Duration:  6 month contract (potential to convert to perm)

As a Regulatory Affairs contractor, you will provide support in the development and implementation of global regulatory CMC strategies for our Partners marketed and development products. You will support regulatory activities for internal and external programs and work closely with cross-functional subject matter authorities to ensure an effective partnership and execution of regulatory requirements and the timely submission and approval of global regulatory filings.
Essential Functions Include:
• Review regulatory submission documents and support regulatory filings
• Interpret regulations and provide well-reasoned regulatory guidance to cross-functional project teams
• Support and lead in the preparation of health authority meeting materials and lead responses to requests for information
• Research, prepare and present on global regulatory topics to internal and external collaborators
• Assure compliance with all applicable regulations including regulatory change management

Requirements:
• Minimum of BS degree in science with minimum 3 years of experience in Regulatory Affairs CMC in the biotech/pharmaceuticals industry (an equivalent combination of education/experience will be considered)
• Proven experience with Health Authorities submissions and a working knowledge of FDA/EMA regulations
• Proven experience and success in applying regulatory knowledge to various situations
• Excellent writing, communication, and interpretive skills
• Experience filing and knowledge of European/global submissions a plus
• Experience in regulatory management of commercial products a plus
In return, we offer you:
• Hybrid work flexibility
• A collaborative, innovative team that works as one to amplify your impact—on your career, the work you do and patients’ lives.


Benefits:
• Comprehensive Medical, Dental, and Vision plans.
• 401k with Company Match to secure your financial future.
• Weekly pay with convenient direct deposit, plus Sick Pay
• Enjoy holidays with our Holiday Pay.
• Monthly Recognition Programs to celebrate your achievements.
• Dedicated Career Partner to help you grow and reach your career goals.
• Join a company recognized as one of the World's Most Ethical Companies in 2023, maintaining this prestigious title for 14 consecutive years.
If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of Experis
ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.