Head of Regulatory Affairs
Our client is a research-based pharmaceutical company. They have asked us to assist them in their search for a Head of Regulatory Affairs
Major tasks and responsibilities will include:
- Leads the Regulatory Affairs team to develop and implement competitive and effective regulatory strategies for products in early development in multiple therapeutic areas, including clinical, nonclinical and CMC aspects and identifies potential risks associated with proposed strategies.
- Provides efficient leadership to ensure that regulatory project goals set by Project Teams are met.
- Ensures that all US regulatory activities are executed in accordance with agreed timelines.
- Offers direct supervision, including oversight, assistance, mentorship, development and performance management of staff.
- Serves as a Regulatory Leader on a project team when necessary.
- Oversees and partakes in the design, evaluation, and submission of regulatory documentation such as INDs, expedited program designations, orphan drug applications, annual reporting, pediatric plans, and amendments related to clinical trials.
- Supervises and operates with the RA team in the developing, reviewing, revising and assembling of summaries, study reports and other technical information to create comprehensible information packages for regulatory applications.
- Maintains knowledge of the US regulatory intelligence, advises the organization of any potential impact on the business with regards to changes in regulations, guidelines, trends or environment, and recommends appropriate course of action.
- Provides advice and direction to project teams on the interpretation and application of relevant regulatory requirements and review processes.
- Oversees appropriate US RA risk identification and management activities, including delivery of risk mitigation strategies impacting company or global activities.
- Contributes toward globalization of organization by collaborating with regional and country regulatory affiliates to support international development activities and harmonize and adopt best practices.
- Works closely with global regulatory leads to present coordinated global regulatory strategies and issues at team or governance meetings.
- Oversees the function and ensures department stays on track to meet goals and objectives.
- Supervises department members, maintains regular communication and provides regular feedback on projects, progress, issues, etc.
- Fully understands and executes the company’s performance evaluation process, including feedback, evaluation ratings, and career/professional development guidance.
- Develops and manages the departmental budget, including forecasts and projections on utilization, closely communicating with Finance & Accounting.
- Maintains frequent and productive communication with Executive Office on departmental goals and objectives, employee development, etc.; provides monthly and quarterly reports.
- Manages the resourcing process by communicating needs to Executive Office, collaborating with HR to develop job requisitions, job descriptions, and identifying appropriate candidates during the hiring process as is needed.
- Responsible for providing guidance, direction, and performance evaluation to the RA team members.
- Coaches and provides expertise to the Global Project Team members in translating the regulatory requirements to carry out a practical and workable strategy and implementation.
We seek candidates with the following qualifications:
- Implements supervisory responsibilities in accordance with the policies and relevant laws.
- A Bachelor’s degree in life sciences, chemistry, or related discipline is required.
- Must have a minimum of 10+ years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the US and global regulatory environment.
- An advanced degree in life sciences, chemistry, or related discipline is strongly preferred.
- Must have experience in managing the activities of one or more functional areas, product or service groups, etc., and overall responsible for the direction of assigned areas.
- Requires strong results-oriented management style and leadership skills.
- Must have the ability to think of new and effective ways to accomplish goals.
- Requires strong interpersonal skills.
- Requires the ability to work effectively with the international team.
- Must plan and set timelines to execute timely submissions.
- Experience with drug development and taking a molecule from pre-clinical to FDA approval is required.
- Having a strong biologics background is preferred.
- Displays knowledge of current US regulations for drugs (NCE and biologics), and has experience in preparing, filing, managing, and submitting major regulatory submissions, including all supportive amendments, supplements, and annual reports to the FDA in eCTD format is essential. Knowledge and experience of requirements outside US (e.g. EU or Asia) preferred.
- Must have knowledge of clinical trial regulations, including experience with submission and management of regulatory aspects of clinical trials in accordance with Good Clinical Practices (GCP) requirements.
- Must have the proven ability to independently manage critical projects as part of an interdisciplinary team.
- Must have experience with leveraging regulatory intelligence activities to optimize regulatory strategies.
- The ability travel 1-3 times per year is required.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.