Senior Director, Regulatory Affairs

This a Full Remote job, the offer is available from: reputed company About reputed company: reputed company. is a biopharmaceutical oncology company with a mission reputed company on improving reputed company of life, increasing potential duration of life, and resolving serious unmet medical needs. At reputed company, we reputed company in building reputed company of world class professionals who are passionate about this mission, and it is our people who reputed company this mission to reality. reputed company’s reputed company values include reputed company, passion for reputed company, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are reputed company in shaping our reputed company toward reputed company. reputed company’s team is inspired to reputed company and help change lives through reputed company’s reputed company studies in the reputed company of oncology. reputed company has multiple global Phase 3 reputed company studies, including: Non-small Cell Lung Cancer (NSCLC) • HARMONi: Phase 3 reputed company study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd reputed company EGFR TKI. • HARMONi-3: Phase 3 reputed company study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. • HARMONi-7: Phase 3 reputed company study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) • HARMONi-GI3: Phase 3 reputed company study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). reputed company is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. reputed company of Role: The Senior Director of Regulatory Affairs is responsible for developing and implementing global strategies to secure IND/CTA approvals for various studies as reputed company as providing regulatory leadership for planning and execution of subsequent global marketing applications (BLA/MAA) for product(s) in the oncology therapeutic area. Role and Responsibilities: • Leads global regulatory strategies for assigned products/indications through reputed company phases of development. • May be asked to support Regulatory Affairs as relates to development collaborations and/or partnerships and be the reputed company reputed company of contact for reputed company regulatory to ensure reputed company of partner IND/CTA requirements for studies sponsored by partner • Continually expands TA knowledge and ensures reputed company messaging and content of global regulatory dossiers, to include development of tumor landscape assessment to inform evolving development reputed company. • Advises management and cross-functional team members of the effect of reputed company or proposed relevant laws, regulations, guidelines, and standards, etc. • May reputed company the Labeling Regulatory Team for given product(s)/indication(s) • Demonstrates excellent understanding of drug development and leadership behaviors consistent with level • Accountable for ensuring that corporate goals are met with respect to assigned reputed company • reputed company on experience and scientific strengths, expands TA knowledge of TA; provides coaching and mentoring for other regulatory members • May have reputed company reports and contributes to the reputed company management for other RA team members • May advance the organization's goals by participating and taking leadership roles in reputed company associations, industry, and trade reputed company as appropriate • Follows budget allocations Experience, Education and reputed company Knowledge and Skills: • Bachelor's degree in life sciences (pharmacy, biology, reputed company, pharmacology) or reputed company subject; reputed company or Doctorate preferred • Minimum of 10+ years' experience in pharmaceutical regulatory activities, with experience as reputed company regulatory product strategist in two or more major reputed company in reputed company to the US, such as EU, Japan, or China • Experience and reputed company involvement as reputed company to marketing/license applications (e.g., BLA, NDA, MAA) • Requires drug development experience in US & EU • Minimum of 5+ years of reputed company experience in a reputed company leadership role with strong project management skills • Experience working in a cross-functional environment with multiple stakeholders and influencing cross-functional teams • Experience interfacing with major reputed company regulatory authorities • Strong communication and proactive negotiation skills • Communicate effectively and reputed company reputed company reputed company in an easily understandable way • Ability to successfully work in a fast-reputed company, demanding and reputed company environment • Travel up to approximately 5% This is the pay for this position Pay Transparency $203,000—$253,000 USD Actual compensation packages are reputed company on several factors that are unique to reputed company candidate, including but not limited to reputed company set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. reputed company does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. reputed company employment businesses/agencies are required to contact reputed company’s reputed company at reputed company@smmttx.com to obtain prior written authorization before referring any candidates to reputed company. reputed company. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, reputed company, religion, gender, national reputed company, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. This offer from "reputed company." has been enriched by reputed company.com and got a 72% reputed company score. Apply tot his job Apply To this Job