US Tech Solutions is seeking a "Associate Director" for a 06+ Months Contract position with a client in North Chicago, IL
Job Poster: Rohit Narayan
The Associate Director Regulatory Affairs Global RA CMC Lead, Regulatory Affairs CMC, works with internal and external partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including clinical applications and marketing applications. Represents CMC on teams to negotiate, influence, and provide strategic advice. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Demonstrates understanding of drug development and leadership behaviors consistent with level.
• Identifies and collects data needed and prepares CMC regulatory product strategies. Seeks expert advice and technical support as required for strategies and submissions.
• Manages the preparation of CMC submissions. Prepares and manages regulatory applications, including new clinical applications and amendments, market applications, renewals, annual reports, supplements/variations under limited supervision. Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.
• Manages products and change control in compliance with regulations and company policies and procedures. Analyzes and approves manufacturing change requests.
• Develops strategies for CMC meetings, support/manage preparation for agency meetings and content of pre-meeting submissions.
• Regularly informs regulatory management of important timely issues.
• Represents CMC regulatory affairs on teams such as the product development and Global Regulatory Product Teams, for assigned projects; negotiates with and influences team members to maximize chances for first pass approval or regulatory submissions.
• Supports combination products and medical devices including design control and change management activities
• Required Education: Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related
• Preferred Education: Relevant advanced degree is preferred.
• 8 years pharmaceutical or industry-related experience. Some portion should include experience related to pharmaceutical
regulatory work. Proven 3+ years in a leadership role with strong management skills.
• Experience working in a complex and matrix environment with multiple stakeholders and on cross-functional teams.
• Strong communication and proactive negotiation skills, both oral and written.
Experience interfacing with government regulatory agencies. Experience developing and
implementing successful global regulatory strategies.
• 5 years' experience in Regulatory Affairs; 10 years pharmaceutical experience (drug/medical device/combination product). 5 years in Discovery, R&D or Manufacturing
• Experience developing and implementing successful global regulatory strategies. Experience working with Health Authority
• Note: Higher education may compensate for years of experience.
About US Tech Solutions:
Your talent, our opportunities - This is the premise behind US Tech Solutions.
You have the skill we have the opportunity. As a team, we work passionately for you to get the right career opportunity across industry verticals and functions. For past sixteen years, leading Global
Companies and Fortune 500 come to us to get the right talent. Whether you want to work as full-time, contractor or part-time, technical or non-technical our talent consultants will connect with the right career opportunity globally.
Connect with our talent team today.
USTECH was founded in 2000 by Manoj Agarwal. Today, we are a global firm offering talent solutions to 150 customers including 20% of Fortune 500 across Financial Services, Healthcare, Life Sciences, Aerospace, Energy, Retail, Telecom, Technology, Manufacturing, and Engineering. We are headquartered in New Jersey with 40 global locations across the USA, Canada, Europe, and India. Deloitte has recognized USTECH as one of the fastest growing private businesses for the past five consecutive years and INC 500 for the past three. We have also been rated "The Top Business in the US" by Diversity Business since 2011. To learn more about how US Tech Solutions visit our website: www.ustechsolutions.com.
"US Tech is an Equal Opportunity Employer" and "US Citizens & all other parties authorized to work in the US are encouraged to apply."
Apply: Interested candidates are requested to send their resume to Rohit at Rohit.email@example.com
Posting ID: 572832611Posted: 2020-09-21