Director Regulatory Affairs

Yoh, A Day & Zimmermann Company; Noblesville (IN); Hybrid; USD 150,400 - 165,000; Full time

Benefits offered by this job

Medical, Prescription, Dental & Vision Benefits

Health Savings Account (HSA)

Life & Disability Insurance

401K Retirement Savings Plan

Certification and training opportunities

Job summary

A leading staffing company is seeking a Director of Regulatory Affairs based in Noblesville, IN. The role involves managing regulatory compliance and submissions for pharmaceutical products while collaborating with global teams to navigate regulatory strategies. Candidates should possess significant experience in the industry and a relevant science degree.

Qualifications

• Minimum fifteen years of relevant experience in the Regulatory Affairs pharmaceutical industry.
• Five years of supervisory experience and matrix management preferred.
• Experience in writing Target Product Profiles and clinical protocol reviews.

Responsibilities

• Manage submissions and projects, ensuring compliance and execution.
• Define Target Product Profile and build compliant dossiers.
• Coordinate communication between Global Business Units and Regional Regulatory Affairs staff.

Skills

Regulatory compliance

Project management

Strategic planning

Education

Bachelor of Science in Chemistry, Pharmacy, Biology or other Life Science

Job description

1 day ago Be among the first 25 applicants

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TheDirector of Regulatory Affairswill need to sit local to St. Louis, Mo, or Noblesville, IN and willbe offering a hybrid schedule. This individual is responsible for regulatory affairs dossiers and associated regulatory affairs compliance and operations activities in the US.Additionalresponsibilities include defining and authoring compliant content for new and existing dossiers, implementing and managing tracking systems, and preparation and submission of electronic drug, biologic, and device applications. This individual will be leading new submissions associated with the chemistry of new chemical entitiesas well as products already being testing in non-clinical and or clinical studies and focus on existing marketed products or those obtained through acquisition.This position willnavigateregulatory projects that may require concept building, target product profile, claims definition, regulatory strategy (including non-clinical and clinical), non-clinical and clinical protocol review, defining dossier table of contents, submission building, health authority management, obtaining approvals, managing post approval commitments, and product launch.

Essential Functions

• Manage submissions and projects as assigned assuring compliance, planning, and execution.
• Process, interpret and provide recommendations for complex strategies.
• Critically review documentation for regulatory submissions and provide input for necessary revisions.
• Define Target Product Profile and build compliant drug and device “approvable” dossiers and registration.
• Serve as Liaison for third party service providers supporting Nuclear Medicine.
• Maintain associated compliance database for tracking individual and department project deliverables for New Submissions and RA Compliance.
• Implement policies, procedures, practices, and strategies for Regulatory Affairs.
• Develop and implement in alignment with regional RA taking local considerations into account.
• Manage multiple, sometimes conflicting priorities, define issues and obstacles, define risk analysis, and execute solutions.
• Execute objectives in alignment with Regulatory Head, Marketing and Global Business Units.
• Coordinate communication between the Global Business Units and the Regional Regulatory Affairs staff resulting in a collaborative relationship.
• 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.
• 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/Education

• Bachelor of Science in Chemistry, Pharmacy, Biology or other Life Science, plus direct experience managing regulatory activities
• Fifteen or more years of relevant experience in the Regulatory Affairs pharmaceutical industry.
• Five or years of supervisory experience of direct reports required matrix management experience preferred.
• 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.
  

#IND-SPG

Estimated Min Rate: $150400.00
Estimated Max Rate: $165000.00


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.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management, Manufacturing, and Science

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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