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, CAPA's 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 PAI's) 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/guidance's 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 science

  • Licenses/ Certifications: Regulatory Affairs Certification (RAC Drugs) preferred

• Experience:

  • 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 preferred

  • Experience 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 skills

• Travel Requirements: 0-5%

You. Unlimited

We believe in creating thegreatest good for society. Our strongest investmentsare in our people and thepatients we serve.

Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about on our website ( ).

Other reasons why you will love it here!

• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
  Work/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 Program

• Flexibility: Hybrid Work Model (For most professional roles)

• Training: Hands-On, Team-Customized, Mentorship

• Extra Perks: Discounts on fitness clubs, travel and more

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.