Associate Director, Oncology GRA

In this role you will

• Be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head for the development of appropriate regional regulatory strategies and their delivery according to plans.
• Collaborate with the Early/Medicine Development Team (EDT/MDT) or GRL to ensure a robust regulatory strategy is in place to support the development program and meet the needs of key markets.
• Work closely with local/regional commercial teams to secure the best possible labelling commensurate with the available data.
• Lead interactions with local/regional regulatory authorities.
• Proactively develop regulatory strategies that meet the needs of the local region(s), while considering the needs of other regions globally. Implement regional strategies in support of global projects.
• Ensure compliance with global/regional requirements at all stages of the product life cycle.

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

• Bachelor’s degree in biological or healthcare science.
• Minimum 2 years of Regulatory Affairs experience including interaction with Regulatory bodies
• Experience managing development, submission, and approval activities in different regions globally.
• Experience in Oncology disease area

If you have the following characteristics, it would be a plus:

• Advanced Scientific Degree (PhD, MD, Pharm
  
  D).
• Knowledge of all phases of the drug development process in regulatory affairs.
• Capability to lead regional development, submission, and approval activities in local region(s).
• Knowledge of clinical trial and licensing requirements in all major countries in the region and, ideally, knowledge of other key Agency processes globally.
• Knowledge of relevant therapy area and the ability to further develop necessary specialist knowledge for the product or area of medicine.
• Creative regulatory problem-solving capabilities, balancing agency expectations and compliance

The US annual base salary for new hires in this position ranges from $134,250 to $223,750. 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.

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

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines.

We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment…