Are you passionate about regulatory advertising and promotion review with oncology experience? Within the Oncology space, we are in a period of very dynamic growth, as we continue to expand and develop our pipeline and portfolio. We are looking for a driven and motivated regulatory professional who will be instrumental in supporting the growth of our expanding oncology portfolio.

 As the Director, Regulatory Advertising & Promotion Policy, you will be responsible for leading assigned products providing sound regulatory advice for advertising and promotion of prescription drug products and biologics that minimizes the risk of regulatory action, competitively positions assigned products and is consistent with applicable FDA regulations and GSK policy.

This role will act as a credible, influential, respected spokesperson for assigned products during interactions with the Office of Prescription Drug Promotion (OPDP) and/or the Advertising and Promotional Labeling Branch (APLB) reviewers. The Director will provide consultative support to Global Regulatory Affairs therapeutic project teams for issues/strategies relating to continuity between development plans and commercial objectives.

Key Responsibilities:

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

•          Provide strategic and operational leadership to Marketing Brand Teams, Legal, Medical Affairs and Clinical in the development of advertising and promotion for the US market (for major company assets) in accordance with business goals and objectives, FDA regulation, PhRMA guidelines and company policy

•          As an internal expert on FDA regulations governing promotion, maintain awareness of evolving regulations and interpretations, advisory comments, enforcement letters and policy issues, and communicate relevant information appropriately to stakeholders

•          Establish and nurture a productive, transparent relationship with OPDP and/or APLB to achieve successful and timely review of advisory submissions and effective resolution of regulatory actions.

•          Advise on the development of US labeling to ensure support for anticipated promotional messages and claims

•          In-depth understanding of labeling for assigned GSK and competitor products and the subsequent translation of that knowledge into the development of promotional materials

•          Competitively position promotional materials that comply with applicable FDA and corporate regulations, policies and guidance

•          Influential member of multiple cross-functional US Pharma, Regulatory Matrix Teams and R&D teams with senior membership

•          Identify continuous improvement opportunities

•          Participate in company working groups that focus on advertising and promotion standards and guidelines

•          Serve as regulatory advertising and promotion lead on cross-functional matrix teams supporting early pipeline assets and pre-launch products for future promotional impact. Provide strategic advice on early assets, launch, and lifecycle product activities (e.g., clinical trial protocols, substantiation for claims, labeling review).

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• 5 or more years of regulatory experience in the development of Pharmaceutical advertising and promotion for the US market (for major company assets)

• Prior work experience interacting with OPDP and/or APLB reviewers

• Experience working on pre-launch activities and launch promotional campaigns

• Experience facilitating groups of individuals to work together on creating solutions

Preferred Qualifications:

• Advanced degree in biological or health care scientific discipline

• 7 or more years of regulatory experience working on multiple products across a range of therapeutic areas.

• Experience supporting Oncology products and experience in advanced areas of science, e.g., Immuno-oncology.

• Demonstrated history of successful interactions with OPDP and/or APLB reviewers

• Experience providing regulatory ad/promo consultations on target medicine profile, clinical trial designs and during labeling development

• Consistent ability to foster strong matrix working.

• Proven track record of facilitating groups of individuals to work together on creating solutions

• Ability to manage and execute on projects independently, with minimal supervision

• Awareness/familiarity working with the digitalization in development and regulatory strategy to enhance decision-making, and drive efficiency and innovation

• Excellent communication skills, both written and verbal

#LI-GSK

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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.