- Ensuring the regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally
- Implementation of the regional strategy(ies) in support of the project globally
- Lead regulatory interactions and the review processes in local region
- Ensuring appropriate interaction with regional commercial teams in local region
- Ensuring compliance with regional requirements at all stages of product life from commit to medicine development (C2MD)
- Ideally able to advocate persuasively approaches to senior leaders in GSK and at Health Authorities
- Capable of providing assessment of potential in-license molecules
- Bachelor's degree in life sciences or pharmacy.
- 5 + years of regulatory affairs experience in the pharmaceutical industry.
- All phases of the drug development process, leading/working on matrix teams involved in developing regulatory strategy, submission, and marketing approval activities in local region(s)/globally. Organizing and executing successful interactions with Health Authorities.
- Development of global/regional clinical trial and licensing requirements.
- PhD or Masters' degree in life sciences or pharmacy.
- Extensive knowledge of relevant area of medicine, or proven track record of being able to develop product / therapeutic knowledge in new area.
- Excellent communication skills, ideally in writing and verbally. Proven ability to deliver key communication with clarity, impact and passion. Commands attention and interest through use of appropriate communication techniques. Proven ability to foster strong matrix working. Capable of facilitating groups of individuals to work together on creating solutions. Ability to lead change and communicate difficult messages. Able to implement plans and hold self and team accountable for delivery of short and medium term goals.
- Proven ability to build strong personal networks, and use them to secure appropriate support and outcome for a project. Developing an external network.
- Ability to proactively recognize and resolve conflict and arbitrate as necessary, seeking help as necessary to ensure successful outcome.
- Proven ability to derive creative solutions to regulatory problems, while balancing the expectations of regulatory agencies and ensuring compliance with regulation in all regions. Will seek information from a broad range of sources, within and outside the normal range of enquiry to understand wider context. Proven ability to take sound decisions, often without complete information, or in situations where consultation with others is not possible due to situation or time constraints. In doing so, the job holder will use all available sources of information and weigh benefits and risks before making important decisions.
- Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Establishes team goals and uses to seek to improve performance, with ability to set challenging but realistic targets.
- Ability to interact with regulatory officials and support advocacy initiatives.
- Significant external network at least into other pharmaceutical companies and recognized as an expert broadly or in specific areas of regulatory affairs.
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Director, Regulatory Affairs Specialty, HIV - Durham, United States - GSK
Description
Purpose:Ensure the development of appropriate regulatory strategy(ies) and their execution for for early and/or late stage HIV or other assigned asset(s) consistent with Medicines Development Strategy/Integrated Asset Plan (IAP). This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data.
Responsibilities and Accountabilities
Accountable to GRL (if one assigned) and/or Global Regulatory therapeutic area (TA) Head for development of appropriate regional and/or global regulatory strategy(ies) and for delivery according to plans. The Regulatory Director may be the single point of contact on assigned asset(s), responsible for regional and global regulatory strategy(ies). In conducting this role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK up to VP level and representing GSK at minimum with the local / regional regulatory agency. Work closely with local / regional commercial team to secure best possible labelling commensurate with the available data. Lead interactions with local / regional regulatory authorities. Lead regulatory matrix teams (RMT) as applicable/relevant.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
If you have the following characteristics, it would be a plus:
Why GSK?
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why Us?
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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or 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.
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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.
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