GSK एक वैश्विक स्वास्थ्य सेवा और दवा कंपनी है, जो दवाओं और टीकों के विकास के लिए वैज्ञानिक अनुसंधान, प्रौद्योगिकी और विशेषज्ञ प्रतिभा को एक साथ लाती है। इसका कार्य रोगों की रोकथाम और प्रबंधन में मदद करने वाले उत्पादों की खोज, निर्माण और आपूर्ति तक फैला हुआ है। यह एक बड़े अंतरराष्ट्रीय संगठन के भीतर स्वास्थ्य सेवा में नवाचार में योगदान देने के अवसर प्रदान करती है।
Global Regulatory Affairs Manager, Oncology
Shape regulatory strategies for GSK oncology medicines, guiding development plans, submissions, and approvals across global markets. Partner with regional teams and authorities to support compliant product development throughout the lifecycle.
संयुक्त राज्य
कैलिफ़ोर्निया
मैरीलैंड
मैसाचुसेट्स$1,38,750 – $2,31,250 / वर्ष
हाइब्रिडपूर्णकालिकजूनियरआवश्यक भाषा: अंग्रेज़ीअनुपालनविवरण
- Develop global and regional regulatory strategies for oncology products.
- Guide labeling and approval activities while ensuring compliance with applicable requirements.
- Work with global regulatory leaders, regional counterparts, local operating companies, and cross-functional teams.
- Shape development plans and regulatory engagement across multiple regions.
- Create regulatory strategies that address the needs of key markets.
- Align regulatory plans with the Medicines Development Strategy and Integrated Asset Plan.
- Support regulatory authority engagement, reviews, and submissions for product development and approval.
- Use regulatory intelligence, precedents, and competitor insights to guide strategy and decisions.
- Maintain compliance with global, regional, and local requirements throughout the product lifecycle.
- Advance process improvement and performance through strategic change.
आवश्यकताएँ
- Bachelor’s degree in a biological, pharmaceutical, or healthcare science.
- At least one year of drug development experience, preferably in regulatory affairs and oncology.
- At least one year of experience with clinical trial requirements in at least one major regional or global market.
- An advanced scientific degree such as a PhD, MD, or PharmD is preferred.
- Experience managing global and regional development, submission, and approval activities is preferred.
- Ability to foster collaboration, proactively resolve challenges, and develop solutions within regulatory constraints is preferred.
- Familiarity with digital fluency tools is preferred.
- Strong written and verbal communication skills are preferred.
- Experience working effectively in matrix teams is preferred.
- Oncology experience is preferred.
- Relevant skills include business resilience, communication, digital fluency, matrix leadership, pharmaceutical regulatory compliance, regulatory strategy, resource management, and stakeholder management.
लाभ
- Competitive salary.
- Annual bonus based on company performance.
- Healthcare and wellbeing programs.
- Pension plan membership.
- Share and savings program.
- Hybrid working arrangement combining remote and office work.
- Annual bonus.
- Eligibility for a share-based long-term incentive program.
- Healthcare and other insurance coverage for employees and their families.
- Retirement benefits.
- Paid holidays.
- Vacation leave.
- Paid caregiver, parental, and medical leave.