Senior Regulatory Affairs Specialist - Fort Worth, United States - Smith & Nephew

Description

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

The Senior Regulatory Affairs Specialist will be responsible for projects by leading biologics CMC regulatory submissions, reviews and approves advertising/promotional materials, provides regulatory input into change controls and CAPAs and support audits/inspections to ensure full compliance for US S+N site.

What will you be doing?Author CMC supplements for FDA and Health Canada to meet the Company's product launch timelines, including drafting, and preparing submissions in eCTD format.

Work closely with project teams to develop regulatory strategies, testing requirements and other documentation per regulatory requirements.
Reviews and approves advertising and promotional materials for biological products. Work collaboratively with cross-functional teams (i.e. Marketing, Legal, Compliance, R&D) to develop and review materials which are compliant with applicable regulations, guidelines, corporate policies and product development objectives.

Reviews and approves change controls for specification, manufacturing process, labeling, CAPAs to ensure compliance with FDA and Health Canada requirements, including compliance with cGMP, and GDP requirements.

Participate and support FDA audits/inspections for the Fort Worth site (including PAIs) and ensure compliance with applicable regulations.
Champions a culture of collaboration, leadership, mutual accountability, critical thinking and continuous improvement within a high-performing team.

Represents Regulatory Affairs with excellence in cross-functional interactions and represent Franchise RA with excellence in interactions with regional RA representatives.

Drafts and maintains applicable policies and procedures supported or owned by the regulatory affairs function.

Stay updated on relevant FDA regulations/guidances and provides notice and summary of the impacts of any changes to the regulatory landscape to the business.

Compiles and maintains regulatory records for regulatory activities and applications.
Performs other duties as assigned.

What will you need to be successful?Education:

Minimum Bachelor's degree required with focus in the area of chemistry, biology or related scienceLicenses/ Certifications: Regulatory Affairs Certification (RAC Drugs) preferredExperience:At least 5 years pharmaceutical or biologics CMC submissions experience with FDA required.

Proven experience in leading successful CMC submissions and liaising with FDA having served as the regulatory lead in Agency interactions.

A deep understanding of scientific principles and FDA regulatory CMC requirements and defining submission strategies required.
Experience in reviewing and approving advertising/promotional assets preferredExperience with eCTD publishing tools desired.
Expert regulatory knowledge within relevant therapy area (pharmaceutical/biologics)Ability to work strategically within complex, business critical and high-profile programs.
Ability to think strategically and critically to evaluate risks to regulatory activities.

Must demonstrate strategic thinking with ability to influence, strong initiative, work ethic and excellent oral and written communication skillsTravel Requirements: 0-5%You.

UnlimitedWe believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website ).

Other reasons why you will love it hereYour Future: 4 01k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition ReimbursementWork/

Life Balance:
PTO, Paid Holidays, Flex Holidays, Paid Community Service Day

Your Wellbeing:
Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance ProgramFlexibility : Hybrid Work Model (For most professional roles)

Training:
Hands-On, Team-Customized, Mentorship

Extra Perks:
Discounts on fitness clubs, travel and more

Job Type:
Full-timePay: Up to $115,000.00 per yearBenefits:401(k)

Dental insuranceEmployee assistance programHealth insurancePaid time offProfessional development assistanceReferral programRelocation assistanceStock optionsTuition reimbursementVision insuranceExperience level:5 yearsSchedule:Monday to FridayExperience:pharmaceutical or biologics CMC submissions: 5 years (Required)defining submission strategies: 3 years (Required)leading CMC submissions and liaising with


FDA:
5 years (Required)

CBE-30: 3 years (Required)

Ability to Commute:
Suite 600 Fort Worth, TX Required)

Ability to Relocate:
Suite 600 Fort Worth, TX 76109: Relocate before starting work (Required)

Work Location:
Hybrid remote in Suite 600 Fort Worth, TX 76109#J-18808-Ljbffr