Regulatory Affairs Senior Associate

This Regulatory Affairs Senior Associate has responsibility for end-to-end regulatory activities for the assigned portfolio. Executes well-constructed and considered regulatory strategies that keep pace with the dynamic regulatory environment. Builds strong relationships with all stakeholders, internal and external.

Key Responsibilities:

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Growth:

• Represent USRA on assigned projects, providing guidance on drug/device/food/cosmetic regulation and developing regulatory strategies. Includes review of formulas for local acceptability and claims development.
• Collaborate with Global and US stakeholders (commercial, Global Reg, R&D etc) to ensure regulatory contributions achieve the objectives in the strategy, achieve agreed standards, to maximize overall project delivery time and Probability of Success
• Provide regulatory support to ex-US markets for brands where US is the Lead Market

Stewardship:

• Support end-to-end regulatory compliance of products in remit.
• Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated.
• Proactively identify potential regulatory risks and recommend solutions within defined scope of responsibility on the business.
• Review labeling and formulations for acceptability.
• Maintain high level of knowledge on the science of products within defined portfolio.

External Engagement:

• Monitor regulatory trends that could impact portfolio.

Why you?

Basic Qualifications

• Bachelor's Degree - Life science/Nutritional sciences/Pharmacy (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)
• Experience with the US OTC Monograph system and previous experience in oral health care
• 2 + years' experience in a pharmaceutical or consumer health environment, direct US regulatory experience preferred

Preferred Qualifications

• Master's degree (MBA, MS, MA), or PhD/PharmD/JD QP - Regulatory Affairs, Pharmacy
• RAC Certification

Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness

*LI-GSK

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.