How to hire a regulatory agency director

How to hire a regulatory agency director, step by step

Here's a step-by-step regulatory agency director hiring guide:

• Step 1: Identify your hiring needs
• Step 2: Create an ideal candidate profile
• Step 3: Make a budget
• Step 4: Write a regulatory agency director job description
• Step 5: Post your job
• Step 6: Interview candidates
• Step 7: Send a job offer and onboard your new regulatory agency director
• Step 8: Go through the hiring process checklist

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1. Identify your hiring needs

   Before you post your regulatory agency director job, you should take the time to determine what type of worker your business needs. While certain jobs definitely require a full-time employee, it's sometimes better to find a regulatory agency director for hire on a part-time basis or as a contractor.

   Determine employee vs contractor status

   Is the person you're thinking of hiring a US citizen or green card holder?

   Yes

   No

   A regulatory agency director's background is also an important factor in determining whether they'll be a good fit for the position. For example, regulatory agency directors from different industries or fields will have radically different experiences and will bring different viewpoints to the role. You also need to consider the candidate's previous level of experience to make sure they'll be comfortable with the job's level of seniority.

   The following list breaks down different types of regulatory agency directors and their corresponding salaries.

   Type of Regulatory Agency Director	Description	Hourly rate
   Regulatory Agency Director	Top executives devise strategies and policies to ensure that an organization meets its goals. They plan, direct, and coordinate operational activities of companies and organizations.	$30-74
   Board Member	Board members are fiduciaries of an organization leading it to its sustainable development. They are elected by its board of directors or its supervisory committee... Show more	$12-95
   Co-Founder	A Co-Founder is an essential member of a company as they complement the skills, vision, and mission of the Founder. Most of the time, the tasks of a Co-Founder revolve around the financial planning and developing strategies that would be beneficial for the company's financial gain and workforce... Show more	$29-86

   Show more

2. Create an ideal candidate profile

   Common skills:

   • Regulatory Agencies

   Responsibilities:

   • Manage departmental and special project economics, including oversight of budgeting, expense management, and reimbursement billing.
   • Keep up-to-date with EU legislation relevant to product responsibilities and provide interpretation of regulatory changes and any potential project/product impacts.
   • Support and coordinate development of internal proprietary eCTD publishing software.

3. Make a budget

   Including a salary range in your regulatory agency director job description is one of the best ways to attract top talent. A regulatory agency director can vary based on:

   • Location. For example, regulatory agency directors' average salary in arkansas is 62% less than in california.
   • Seniority. Entry-level regulatory agency directors 58% less than senior-level regulatory agency directors.
   • Certifications. A regulatory agency director with certifications usually earns a higher salary.
   • Company. Working for an established firm or a new start-up company can make a big difference in a regulatory agency director's salary.

   Average regulatory agency director salary

   $99,571yearly

   $47.87 hourly rate

   ---

   Entry-level regulatory agency director salary

   $64,000 yearly salary

   Updated December 25, 2025

4. Writing a regulatory agency director job description

   A good regulatory agency director job description should include a few things:

   • Summary of the role
   • List of responsibilities
   • Required skills and experience

   Including a salary range and the first name of the hiring manager is also appreciated by candidates. Here's an example of a regulatory agency director job description:

   Regulatory agency director job description example

   The Regulatory CMC Director will be responsible for preparing CMC and Quality related health authority agency correspondence and regulatory applications, as well as govern CMC submissions and regulatory compliance support for the development of global products. This position will lead all regulatory activities to support high quality CMC sections of regulatory documentation.
   Primary Responsibilities:
   
   * Provide regulatory CMC strategic leadership within Regulatory and on cross-functional teams to support development of innovative genomic medicines/cell therapies.
   * Develop and proactively communicate regulatory CMC strategies, risks and key issues in an evolving regulatory landscape.
   * Act as the regulatory CMC lead and department representative in matrix teams for development programs.
   * Support development of manufacturing, analytical, and supply chain strategies and provide expert regulatory guidance to enable global implementation.
   * Define CMC content (data and documentation) requirements for quality sections of regulatory dossiers (IND/CTA/MF and BLA/MAA).
   * Plan and manage activities for the preparation of high quality CMC-related global regulatory submission elements, including authoring and/or critical review to ensure compliance with regulatory requirements, scientific excellence, accuracy, source information traceability, and consistency with related filings in accordance with program timelines.
   * Providing critical review of detailed scientific information described in CMC documents and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
   * Evaluation of CMC-related change proposals for regulatory impact and filing requirements; provide strategic regulatory guidance for optimal implementation of changes.
   * Develop regulatory processes and procedures to support CMC components of regulatory submissions.
   * Support the creation and maintenance of CMC submission templates and dossier standards.
   * Lead and support global health authority interactions for CMC-related topics including defining strategy, preparation, and meeting facilitation.
   * Support Quality Assurance in preparing and hosting GMP and pre-approval inspections.
   * Develops and maintains collaborative partnerships with key internal and external stakeholders.
   * Participate in regulatory intelligence activities, monitor regulatory guidelines and trends as they pertain to global CMC regulations and guidance, and provide regulatory advice to CMC and project teams regarding the applicability/impact on internal programs; anticipate and communicate possible regulatory paradigm shifts.
   
   Qualifications, Knowledge and Skills:
   
   * BA/BS degree in a scientific/engineering discipline.
   * 10+ years experience in the biotech industry.
   * 5+ years experience in Regulatory CMC, or related experience (e.g., manufacturing, analytical, quality assurance) as a strong dossier preparation contributor for IND/CTA/MF and BLA/MAA submissions.
   * Comprehensive knowledge of regulatory (FDA. EMA, and ICH) guidelines; with a demonstrated ability to articulate and apply these principles to regulatory CMC strategies for novel products.
   * Diverse experience including biologics in the cell therapy space, drugs, and international filings preferred.
   * Strong experience with CTD format and content regulatory filings.
   * Excellent organizational, written/oral communication, and time management skills; ability to communicate complex issues in a succinct and logical manner; strong listening skills.
   * Experience with related CMC disciplines (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
   * Ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders; flexibility in responding to changing priorities and/or unexpected events.

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5. Post your job

   There are various strategies that you can use to find the right regulatory agency director for your business:

   • Consider promoting from within or recruiting from your existing workforce.
   • Ask for referrals from friends, family members, and current employees.
   • Attend job fairs at local colleges to find candidates who meet your education requirements.
   • Use social media platforms like LinkedIn, Facebook, and Twitter to reach potential job candidates.

   Post your job online:

   • Post your regulatory agency director job on Zippia to find and recruit regulatory agency director candidates who meet your exact specifications.
   • Use field-specific websites.
   • Post a job on free websites.

6. Interview candidates

   Recruiting regulatory agency directors requires you to bring your A-game to the interview process. The first interview should introduce the company and the role to the candidate as much as they present their background experience and reasons for applying for the job. During later interviews, you can go into more detail about the technical details of the job and ask behavioral questions to gauge how they'd fit into your current company culture.

   It's also good to ask about candidates' unique skills and talents to see if they match your ideal candidate profile. If you think a candidate is good enough for the next step, you can move on to the technical interview.

   The right interview questions can help you assess a candidate's hard skills, behavioral intelligence, and soft skills.

7. Send a job offer and onboard your new regulatory agency director

   Once you've selected the best regulatory agency director candidate for the job, it's time to write an offer letter. In addition to salary, this letter should include details about the benefits and perks you offer the candidate. Ensuring that your offer is competitive is essential, as qualified candidates may be considering other job opportunities. The candidate may wish to negotiate the terms of the offer, and you should be open to discussion. After you reach an agreement, the final step is formalizing the agreement with a contract.

   It's also good etiquette to follow up with applicants who don't get the job by sending them an email letting them know that the position has been filled.

   After that, you can create an onboarding schedule for a new regulatory agency director. Human Resources and the hiring manager should complete Employee Action Forms. Human Resources should also ensure that onboarding paperwork is completed, including I-9s, benefits enrollment, federal and state tax forms, etc., and that new employee files are created.

8. Go through the hiring process checklist

   • Determine employee type (full-time, part-time, contractor, etc.)
   • Submit a job requisition form to the HR department
   • Define job responsibilities and requirements
   • Establish budget and timeline
   • Determine hiring decision makers for the role
   • Write job description
   • Post job on job boards, company website, etc.
   • Promote the job internally
   • Process applications through applicant tracking system
   • Review resumes and cover letters
   • Shortlist candidates for screening
   • Hold phone/virtual interview screening with first round of candidates
   • Conduct in-person interviews with top candidates from first round
   • Score candidates based on weighted criteria (e.g., experience, education, background, cultural fit, skill set, etc.)
   • Conduct background checks on top candidates
   • Check references of top candidates
   • Consult with HR and hiring decision makers on job offer specifics
   • Extend offer to top candidate(s)
   • Receive formal job offer acceptance and signed employment contract
   • Inform other candidates that the position has been filled
   • Set and communicate onboarding schedule to new hire(s)
   • Complete new hire paperwork (i9, benefits enrollment, tax forms, etc.)

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