Sr. Principal Regulatory Affairs - CMC

General Summary

(Remote Position)

The Senior Principal, Regulatory Affairs Specialist, CMC, will manage and oversee development of regulatory strategies for aspects of project(s) or product(s), filing of applications, and interactions with health authorities pertaining to CMC issues or inquiries. Manage and mentor Regulatory Affairs CMC staff and external consultants.

Essential Duties

• Actively understand and interpret industry trends and health authority's expectations in areas related to CMC. Influence and communicate how these trends align with strategic department direction and vision.
• Responsible and accountable for the development and execution of CMC strategies and activities associated with assigned development with assigned project(s) and product(s).
• Assists with the development of RA Department goals in alignment with corporate objectives
• Manage CMC staff as determined by the Director/Associate Director and provide functional and technical guidance and leadership to direct reports and colleagues. Prioritize resources and delegate assignments to direct reports, as required.
• Collaborate with equivalent cross-functional colleagues concerning CMC interests to meet project milestones.
• Mentor and support team members within and outside CMC.
• Accountable for RA CMC activities on cross-functional teams as assigned.
• Lead in regulatory due diligence activities as assigned.
• Maintain cross-functional awareness of and expertise in ICH, FDA and EU guidelines related to regulatory topics.
• Liaison with business partners on regulatory matters on assigned programs.
• Collaborate with RA senior management to create and implement policies, processes, and procedures supporting the department goals and objectives.

Minimum Requirements

• A minimum of a Bachelor's degree in related science field. An advanced degree is preferred.
• Minimum of 14 years (minimum 9 years with MS, minimum 7 years with PhD) regulatory experience in the pharmaceutical industry, with experience in a multi-project environment required.
• The candidate must have proven ability to lead and work effectively in cross-functional teams.
• Minimum of 3 years of demonstrated leadership skills.
• With a Doctorate a minimum of 9 years of relevant pharmaceutical experience, including Regulatory CMC, with a Master's degree 12 years of pharmaceutical experience and with a Bachelor's degree a minimum of 14 years of pharmaceutical experience is required.

Other Knowledge, Skills and Abilities

• Extensive knowledge of US CMC regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues.
• Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes and related issues, drug laws, regulations and guidelines.
• Comprehensive knowledge and experience in CMC sections for investigational and marketed product submissions for FDA.
• Must have strong strategic and critical thinking, leadership, diplomacy and negotiation skills.
• Excellent written and verbal communications skills.
• Must be able to effectively communicate with scientists at all levels.
• Demonstrated ability to work in and lead effectively in matrix teams.
• Strong organization and time management skills.
• Demonstrated ability to influence based on experience, facts and data.
• Preferred experience with biologics, biopharmaceutical manufacturing and/or filing of BLAs.
• Experience with filing and maintaining Type V DMFs for sterile processes.

Travel Requirements

Less than 10%

Compensation Range:

Upsher-Smith Laboratories, LLC is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rightscommission activity, status as a protectedveteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.