About INOVIO
INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO's technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit www.inovio.com. Job summaryThe Senior Director, Regulatory Affairs, Combination Products will have a broad span of responsibilities for leadership of regulatory strategy, regulatory submissions, and health authority interactions.
The position may have direct and/or indirect personnel management responsibilities. The Senior Director, Regulatory Affairs, Combination Products will ensure INOVIO’s compliance with internal SOPs, local, regional, national, and international regulatory laws, standards, and regulations. An important priority will be to ensure strong coordination and collaboration with leaders within Regulatory Affairs and across the INOVIO organization in the development of complex device and combination products in the early to late-stage pipeline.Essential job functions and duties
- Develop and maintain global regulatory strategy for device/combination product during product life cycle.
- Provide regulatory expertise and guidance on device and combination product regulations and requirements. Strategically interpret, plan, and communicate requirements to ensure regulatory authorizations are obtained.
- Provide input, review and recommendations for device design inputs & outputs, verifications and validations. Provide regulatory support to product development teams in the application of key technical standards for Electrical Safety (IEC 60601), Software life cycle processes (IEC 62304), Usability Engineering (IEC 62366), Packaging and Sterilization standards. Review and approve data and documentation required for medical device/combination product regulatory submissions.
- Organize and compile device regulatory submissions and other correspondence to health authorities in support of INOVIO’s pharmaceutical/medical device combination products.
- Interact with key personnel in regulatory agencies to ensure the review and approval of applications and the timely resolution of issues.
- Effectively plan, organize, and conduct formal meetings/teleconferences with regulatory agencies for designated programs
- Provide interpretive analyses of standards, regulatory guidance documents, regulations, proceedings, or directives that impact products, operations and development programs
- Maintain up-to-date knowledge of the data, information, and formats required for inclusion in these applications
- Participate in internal and external quality system audits. Collaborate with INOVIO’s Quality Assurance and Engineering groups for maintaining compliance with applicable regulatory standards (e.g. FDA, MDR, ISO 13485 & ISO 14971)
Minimum requirements
- Bachelor/Master’s degree in engineering or a related area required
- A minimum of 10 years of prior pharmaceutical/biotechnology industry experience, including at least 8 years in medical devices/combination products.
- Significant experience and knowledge of the relevant current requirements for medical device and combination product submissions to FDA, prior interaction or exposure with other key regulatory authorities (e.g. EU Notified Bodies, Latin America etc.) preferred.
- Experience with preparation of master files, INDs, (s)BLA/(s)NDA/MAA and Health Authority meeting briefing documents.
- Excellent oral and written communication, interpersonal and organizational skills, and attention to detail
- Ability to interact effectively with management and prioritize multiple projects
- Technical proficiency, effective problem solving and critical thinking skills
- Ability to work independently and in a team environment, with strong leadership, negotiation and influencing ability.
- Experience contributing to multidisciplinary matrixed project teams; regulatory project leadership preferred.
- Proven ability to successfully manage major submissions and critical projects to deadlines.
- Proven ability to successfully interact with regulatory authorities.
- This position may require approximately 10% travel, both international and domestic.
INOVIO offers a variety of competitive compensation & benefits to regular full time INOVIO employees including:
- 401(K) retirement plan with Corporate Matching
- Annual Incentives
- Medical, Dental, and Vision
- Generous Paid-time off program and company holidays
- Hybrid work environment (Depending on the nature of your employment with INOVIO)
- Physical, Mental, & Financial Wellness Program
- Company-paid Life Insurance plans
- Long & Short-Term Disability
- Flexible Spending accounts for medical and dependent care expenses
- Employee Discount Perks and so much more…
The annualized base salary range for this role is $243,000 to $288,000 and is bonus eligible. Individual pay decisions ultimately depend on various factors including, but not limited to, relevant experience, knowledge, skills, education, geography, internal equity and alignment with external market data.
Disclaimer
INOVIO Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, INOVIO will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, gender identity and expression, religion, marital status, registered domestic partner status, age, national origin or ancestry, military or veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.A current US work authorization is required.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. INOVIO offers an attractive benefits package and is an equal opportunity employer.
Important notice to employment businesses/agencies
INOVIO does not accept referrals from employment agencies unless written authorization from the INOVIO Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore INOVIO will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at INOVIO.
