Director, Regulatory Affairs

POSITION SUMMARY:

The Director, Regulatory Affairs, will be responsible for leading regulatory activities for one or more products through all stages of a product’s lifecycle.   The Director may manage a group of individuals responsible for developing global regulatory strategies and collaborating with key stakeholders to execute the strategies in alignment with business priorities. The Director will be expected to provide guidance to the product teams supporting products in their portfolio.  In addition, the individual will be responsible for preparation, review, and approval of related agency correspondence and regulatory applications.  The candidate will need to successfully manage multiple projects in a fast-paced and results-oriented environment to deliver on bringing new products to market.  Effective communication skills will be critical to overall success.  The individual will also be expected to mentor and develop their direct reports.

PRIMARY RESPONSIBILITIES:

• Develop / implement effective regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks
• Provide guidance for product development projects
• Review documents for submission-readiness to ensure that all submissions conform to health authority guidelines
• Lead Regulatory discussions and interactions with health authorities to facilitate review and approval of submissions
• Develop regulatory processes and procedures to support regulatory submissions
• Works with Quality Assurance to develop / implement a pharmacovigilance program
• Works with Quality Assurance to establish annual product quality review
• Support the creation and maintenance of CMC submission templates
• Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls
• Perform assessment of manufacturing change controls
• Provides interpretation of regulatory guidance documents, regulations, and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs
• Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases)

 

QUALIFICATIONS:

• Minimum 10 years’ experience (BS degree), 8 years’ experience (MS degree), or 6 years’ experience (PhD) in pharmaceutical/biotech industry, manufacturing and/or analytical focus, advanced degree preferred. Experience with biologics a plus.
•   BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required

 

KNOWLEDGE, SKILLS, AND ABILITIES:

•    Strong knowledge of current US CMC regulations, including CTD format and content of CMC regulatory submissions,
•    Knowledge of current CMC regulations outside of the US, as well, is preferred
•    Hands-on experience in managing the preparation and timely submission of regulatory applications, such as US IND or CTA, is required. Regulatory expedited program submissions, CMC, and EU CTA experience is a plus
•    In-depth knowledge of global regulatory requirements, guidelines, and processes for drug development and approval
•    Experience with managing third-party vendors, regulatory operations, and consultants is a plus.
•    Ability to effectively collaborate in a dynamic, cross-functional matrix environment to meet critical regulatory milestones
•    Ability to work independently
•    Exceptional written and oral communication
•    Strong computer skills, including knowledge of Excel, Word, PowerPoint, Outlook, and MS Project/Smartsheet.

 

 

 

 

 

 

 

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.Remote USA$172,700—$215,900 USD

OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the indu