CAREER PORTAL

Senior Regulatory Affairs Manager

Yoh is hiring for a Sr. Manager Regulatory Affairs for our pharmaceutical client in Noblesville, Indiana. This is a great opportunity to join a growing team.

Title:  Sr. Manager Regulatory Affairs
Location: Noblesville, IN (onsite) 
Pay:$50-$72/hr
Type: Intially a 6 month contract


Summary of Position
The Senior Manager of Regulatory Affairs is responsible for Nuclear Medicine Regulatory Affairs dossiers and associated regulatory affairs activities in the US. The responsibilities include, yet are not limited to, defining and or authoring compliant content for new and existing dossiers,implementing and managing tracking systems, and preparation of electronic submissions. The main focus of this position will be on new submissions associated with new chemical entity (NCE) with a secondary focus on existing marketed products orthose obtained through acquisition.

Essential Functions

• Manage submissions and projects as assigned by Regulatory leadership assuring compliance, planning, and execution
• Represent regulatory on cross-functional teams
• Process, interpret and provide recommendations for complex strategies
• Provide regulatory and technical expertise to cross-functional teams
• Critically review documentation for regulatory submissions and provide input for necessary revisions
• Develop and implement regulatory strategies for CMC aspects of drug development and registration
• Lead the preparation and submission of CMC sections of regulatory documents (e.g.,INDs, NDAs, BLAs, MAAs) in compliance with global regulations and guidelines
• Contribute to defining Target Product Profile and build compliant drug “approvable”dossiers and registration
• Serve as Liaison for third party service providers
• Maintain associated database for tracking individual and department project deliverables for regulatory submissions and milestones
• Develop and implement policies, procedures, practices, and strategies for Regulatory Affairs, based on current Health Authority guidelines and regulations
• Manage multiple, sometimes conflicting priorities, define issues and obstacles, define risk analysis and execute solutions
• Execute objectives in alignment with Regulatory leadership, Marketing, and Global Business Units
• Communicate regulatory governmental policy changes to management in a timely manner and provide plans for meeting and complying with new requirements. Understand and recommend strategies based on current local registration requirements and applicable industry standards
• Supports the professional development of regulatory staff through mentorship and guidance
• Present to upper management at required intervals and effectively communicate successes and challenges
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)

Requirements

• Bachelor of Science in Chemistry, pharmacy, biology or other life science, plus direct experience managing regulatory activities.
• Twelve or more years of relevant Regulatory Affairs pharmaceutical industry experience.
• Two years of supervisory experience of direct reports required, matrix management experience preferred.
• In-depth knowledge of global CMC regulatory requirements, guidelines, and industry practices.
• Experience in leading new project submission efforts including strategy, compilation,submission, and approval by a health authority.
• Experience writing Target Product Profiles, non-clinical studies, reviewing Clinical protocols and summary reports.
• Preparing for and executing Health Authority meetings.

 



Estimated Min Rate: $50.40
Estimated Max Rate: $72.00


What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.