Manager/Associate Director, Therapeutic Group, Global Regulatory Affairs
Shpehouston, Champaign, IL, United States
Position Summary
We are seeking a talented individual with Regulatory Affairs knowledge/experience and interpersonal skills to join our Respiratory, Immunology & Inflammation (RII) Global Regulatory Strategy team.
As a valued member of the Regulatory Matrix Team and the asset project teams, you will be empowered to develop appropriate regional regulatory strategies and ensure their execution for assigned assets. This will be consistent with the Medicines Development Strategy/Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile and secures the best possible labelling commensurate with the available data.
Key Responsibilities
Proactively develop regulatory strategy that will deliver the needs of the local region(s), taking into account the needs of other regions globally.
Implement the regional strategy(s) in support of the project globally
Lead regulatory interactions and the review processes in local region
Ensure appropriate interaction with global/regional counterparts and commercial teams in local region
Ensure compliance with global/regional requirements at all stages of product life
Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset
Basic Qualifications
Bachelor's degree in Biological Sciences, Healthcare Sciences, or a related field required
Experience in all phases of the drug development process in regulatory affairs.
Preferred Qualifications
Advanced degree (e.g., PhD) preferred.
Knowledge of clinical trials and licensing requirements in all major countries in the region and ideally knowledge of other key agency processes globally.
Good communicator who can deliver key communications with clarity, impact, and passion.
Strong listening and comprehension skills, with the ability to proactively identify potential issues and elevate as required.
Proficient in digital tools and systems to enhance project delivery and drive efficiency and innovation.
Ability to foster collaborative working relationships and work effectively within cross‑functional teams.
Work Arrangement This role is hybrid. Regular on‑site collaboration is expected. Typical schedule will be two to three days on‑site per week.
Salary & Benefits If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $138,600 to $231,000. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Accommodation If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at usrecruitment.adjustments@gsk.com.
Equal Opportunity Statement GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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As a valued member of the Regulatory Matrix Team and the asset project teams, you will be empowered to develop appropriate regional regulatory strategies and ensure their execution for assigned assets. This will be consistent with the Medicines Development Strategy/Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile and secures the best possible labelling commensurate with the available data.
Key Responsibilities
Proactively develop regulatory strategy that will deliver the needs of the local region(s), taking into account the needs of other regions globally.
Implement the regional strategy(s) in support of the project globally
Lead regulatory interactions and the review processes in local region
Ensure appropriate interaction with global/regional counterparts and commercial teams in local region
Ensure compliance with global/regional requirements at all stages of product life
Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset
Basic Qualifications
Bachelor's degree in Biological Sciences, Healthcare Sciences, or a related field required
Experience in all phases of the drug development process in regulatory affairs.
Preferred Qualifications
Advanced degree (e.g., PhD) preferred.
Knowledge of clinical trials and licensing requirements in all major countries in the region and ideally knowledge of other key agency processes globally.
Good communicator who can deliver key communications with clarity, impact, and passion.
Strong listening and comprehension skills, with the ability to proactively identify potential issues and elevate as required.
Proficient in digital tools and systems to enhance project delivery and drive efficiency and innovation.
Ability to foster collaborative working relationships and work effectively within cross‑functional teams.
Work Arrangement This role is hybrid. Regular on‑site collaboration is expected. Typical schedule will be two to three days on‑site per week.
Salary & Benefits If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $138,600 to $231,000. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Accommodation If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at usrecruitment.adjustments@gsk.com.
Equal Opportunity Statement GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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