Director of Regulatory Affairs

Aktiv Pharma Group is a fast-growing company focused on addressing unmet medical needs through a proprietary drug delivery system. We are currently hiring for a Director of Regulatory Affairs.

The Director, Regulatory Affairs will help develop the strategic direction and execute the tactical operational aspects of global regulatory compliance and submissions for drug-device combination products that include novel drug-delivery systems. This position will be responsible for developing and tracking the regulatory strategy from pre-IND through pivotal clinical trials which may include 505(b)(2) submission types, to commercialization through NDA. This position will manage the regulatory team and contractors, direct execution of all regulatory submissions, facilitate regulatory communications, develop strong relationships with the FDA and other global regulatory agencies.

At Aktiv Pharma Group, we value the diversity of perspectives and backgrounds our employees bring. We are committed to achieving a diverse workforce through application of our equal opportunity employment policy and by providing a work environment free of discrimination and harassment. We work according to our values of truth, caring, goodness and perseverance, and encourage individuals with the required skill-sets and these values to apply.

The compensationrange for the Director of Regulatory Affairs is $160,000- $190,000 annually.

Aktiv Pharma Group offers a wealth of benefits to our employees and their families.

Employee Benefits Include:

• Medical Insurance (Cigna):
  • HDHP – Aktiv contributes the full monthly premium for the employee and their dependents.
  • Two additional premium medical plan options – Aktiv contributes a portion of the monthly premium for the employee and their dependents.
• Vision Insurance (Principal/ VSP Network)
  • Aktiv contributes the full monthly premium for the employee and their dependents.
• Dental Insurance (Principal)
  • Low Plan - Aktiv contributes the full monthly premium for the employee and their dependents.
  • High Plan - Aktiv contributes a portion of the monthly premium for the employee and their dependents.
• Legal & ID Shield
  • Aktiv contributes the full monthly premium for the employee and their dependents.
• Spending Accounts (Rocky Mountain Reserve)
  • FSA
  • HSA
  • DFSA
  • LP FSA
• Ancillary Benefits (Colonial Life)
  • Accident
  • Group Medical Bridge
  • Voluntary Life AD&D
  • Disability
• 401k (Human Interest)
• Unlimited Paid Time Off
• Bi-Monthly Internet and Cell Phone stipend
• Fully Paid Membership for the employee and their dependents to Lifetime Fitness
• Fully stocked office kitchen – Health conscious and Vegan!
• Remote Work Options

Essential Duties/Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Manage Aktiv’s regulatory team and regulatory consultants/contractors
• Develop and maintain regulatory timelines for each project in Aktiv’s portfolio
• Develop and maintain department budget, including management of external regulatory operations contracts
• Develop and implement a regulatory strategy and execute related activities needed to achieve regulatory agency approval for Aktiv’s portfolio of combination products.
• Develop and implement strategies in collaboration with other internal departments to ensure development and manufacturing activities are sufficient to meet regulatory submission and approval expectations.
• Participate in the development of non-clinical and clinical strategies in collaboration with other internal departments and external consultants.
• Serve as the regulatory point of contact with external customers and their regulatory representatives
• Develop a process and direct the submission of regulatory applications, annual reports and documents for the FDA and other regulatory agencies.
• Provide expertise in the development of responses to questions or deficiency letters from regulatory agencies.
• Actively support the regulatory submission process, including acting as a point of contact for FDA or other regulatory agencies.
• Provide internal guidance to ensure regulatory compliance of combination products with the FDA and other applicable regulatory jurisdictions, identifying and assessing regulatory risks.
• Maintain current knowledge of regulations, applicable to Aktiv Pharma Group
• Monitor regulatory affairs and the effect changes will have on company operations and products.
• Ability to establish proficiency in emergency auto-injector regulatory requirements.
• Develop and maintain professional relationship in federal, state, and local regulatory agencies.
• Maintain regular and punctual attendance.
• Perform other additional duties, responsibilities and tasks as directed.

Job Qualifications

Competencies, Knowledge, Skills, and Abilities:

• Knowledge/background of applicable US government regulations
• Demonstrated experience with all levels of domestic regulatory submissions, preferably in combination products but at a minimum with drugs, biologics or devices (e.g., IDE, IND, PMA, 510(k), NDA, BLA etc.)
• Knowledge of international regulatory processes preferred.
• Experience working directly with the FDA preferred (with other regulatory agencies optional)
• Experience working in the FDA 505(b)(2) pathway preferred.
• Ability to inform and educate personnel on emerging regulations and policies that impact company’s products and operations.
• Strategic planning, analytical and problem-solving skills required; in addition to a continued desire to provide tactical execution at all levels.
• Proven leadership skills, along with problem solving ability and creativity.
• Positive, self-motivated, detailed oriented.
• Effective oral and written communication skills to communicate in both formal and informal settings.
• Ability to work independently and well within a team.
• Proficient with applicable database and compliance software.
• Proficient with Microsoft Office Suite or similar software.

Experience and Education

• Bachelor’s degree or higher in a technical or clinical discipline (engineering, biology/ life sciences)
• A minimum of 12 years of experience in regulatory in the medical device/pharmaceutical/ biologics/combination product industry.
• An equivalent combination of education and experience may be substituted on a year-to-year basis.

Additional Requirements/Licenses/Certifications:

• Regulatory Affairs Certification preferred
• Must have reliable transportation.
• Valid driver’s license.