Director, Regulatory Affairs
Director, Regulatory Affairs
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Job Description
Kalo is a global leader in drugdelivery device technology and autoinjector innovation providing millions of patients and emergency responders with security and peace of mind. In addition to our commercial portfolio Kalo has secured multiple contracts with the U.S. government for production of new medical countermeasures with commercialization opportunities to follow. The Director Regulatory Affairs will serve in a dual role focusing on new product development programs and oversite of all nonclinical work executed on Kalos behalf by vendors and CROs. This person will have a critical role in the successful execution of these projects as a managementlevel leader within Regulatory Affairs reporting directly to the head of the Regulatory Affairs team and working closely with Kalos Chief Development Officer.
Responsibilities for this role will include strategic leadership at the managementlevel within assigned functional areas premarket regulatory strategy and compliance(postmarket as needed) and direct interaction with external regulatory CROs/consultants partners (e.g. U.S Department of Defense) the US FDA and other regulatory bodies. The Director will also serve as an internal regulatory affairs subject matter expert (SME) on investigational programs and development. Ownership of nonclinical oversite in this role will involve overseeing vendors and CROs on nonclinical development plans assessing risks managing budgets and FDA approval strategies overseeing expert consultants in nonclinical technical areas and facilitating the execution of nonclinical studies.
At Kalo you will have direct responsibility for assets within the development portfolio and will work collaboratively with all levels of Regulatory Affairs and Development. On any given day you will work across a spectrum of regulatory and nonclinical issues for both drug and device regulations. Regulatory Affairs plays a key role in planning the development of new products here. You will be part of a closeknit fiercely collaborative team that takes pride in being the best at what they do.Kalos remotefirst culture will offer you theflexibility to choose your work location and schedule placing an emphasis on selfmanagement and adherence to deadlines. At Kalo you can feel confident that your work has a tangible impact.
As Director Regulatory Affairs you will hold responsibilities in the following areas:
Regulatory Strategy
- Maintain knowledge of new regulatory requirements and interpret existing requirements as they relateto Kaleos products procedures testing and record keeping; communicate relatedrequirements to team members and upper management.
- Develop and implement regulatory strategies for programs in all phases of development.
- Conduct program meetings to assign and manage plans roles responsibilities and timelines.
- Lead development of regulatory proposals for new programs.
- Lead regulatory evaluation and execution for Pediatric Research Equity Act compliance Orphan Drug designation regulatory accelerated pathways (i.e. Breakthrough designation Fast Track Priority Review) and Emergency Use Authorization.
Regulatory Affairs
- Lead interactions with personnel at regulatory agencies partners (corporate and government) and vendors.
- Lead regulatory meetings: own preparation of meeting packages meeting logistics preparation of subject matter experts and overall meeting leader.
- Accountable for preparation and timely submission of regulatory submissions including INDs NDAs Annual Reports periodic safety reports responses to information requests and briefing documents.
- Review and approve development plans design and manufacturing changes nonconforming materials reports rework orders test protocols and reports to ensure compliance with regulations.
- Advise on international product registration and import/export approval requirements.
- Ensure compliance with PDUFA prescription drug program fee payment.
Nonclinical
- Work with consultants to identify study types and requirements for development programs and develop nonclinical program strategy.
- Manage consultants CROs and associated budgets.
- Qualify labs as needed.
- Review and approval protocols and reports.
- Oversee study execution.
- Accountable for Nonclincial Policies and Standard Operating Procedures to facilitate compliance with regulations.
A successful Director Regulatory Affairs will have:
- Impeccable attention to detail and commitment to flawless execution of regulatory submissionsand other critical work product.
- Demonstrated leadership skills including the ability to think strategically excellent interpersonal communication and the desire and ability to develop and motivate teammates at all levels.
- Proven ability to excel in a fastpaced environment and manage competing priorities.
- A resultsdriven and outcomeoriented approach to work.
- Strong analytical skills with the ability to evaluate technical data review reports and synthesize information with a regulatory mindset.
- The ability to impactfully communicate complex information to broad internal stakeholders and external partners.
- Strong intellectual curiosity and desire to be part of an innovative organization.
- Commitment to inclusivity at the team and organization level.
To be considered for the position you must have:
- Degree in a scientific discipline.
- At least 8 years of increasing responsibility in the pharmaceutical biotechnology and/or ormedical device industries.
- A least 5 years of increasing responsibility specifically within regulatory affairs with at least 3 years managing assigned areas independently.
- Direct experience with pharmaceutical regulatory submissions including electronic submissions in the United States.
- Experience with all aspects of regulatory affairs from preclinical through postmarketing.
- Experience in reviewing nonclinical strategies protocols and reports.
- Ability to travel up to 25%.
- A proven track record of effective collaboration with regulatory agencies specifically the Food& Drug Administration including the successful completion of New Drug Application(s) (NDA).
Preferred qualifications:
- Advanced degree strongly preferred (PhD level).
- Regulatory Affairs Certification preferred.
- Drug/device combination product experience preferred.
- Experience working on government contracts preferred.
Application required for consideration. Please contact with any additional questions.
Required Experience:
Director
Employment Type
Full Time
