Executive Director - Regulatory Affairs
To see similar active jobs please follow this link: Remote Management jobs
Who we are…
Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer.
What you’ll be doing
The Executive Director, Regulatory Affairs reports directly to the Chief Regulatory Officer and will be responsible for providing global regulatory leadership and direction to support the development, registration, and life-cycle management of innovative programs for Nuvation Bio. The Executive Director, Regulatory Affairs will oversee the content and preparation of all regulatory documents and submissions related to applicable programs. Additionally, this individual will mentor junior members of the regulatory team and anticipate and plan for changes in FDA, EU, and other relevant, global regulations and requirements.
You will be responsible for…
Provide global regulatory leadership to support development of multiple, innovative therapies for oncology programs
Lead and develop a high performing regulatory team supporting their career devel
Partner with key team members to develop strategies to advance program from IND through pivotal studies and registration, leveraging a deep understanding of the landscape of oncology development and commercialization
Partner and work closely with Nonclinical, CMC, Quality, and Clinical to ensure achievement of submission deadlines, and obtain timely approvals of clinical trial applications
Drive the planning and implementation of meetings with regulatory authorities and effectively represent Nuvation Bio with regulatory interactions
Understand and interpret complex scientific issues for assigned projects as they relate to regulatory requirements and strategy for assigned projects, and provide knowledge and expertise to guide the team in appropriate regulatory strategy
Proactively identify regulatory issues; offer creative solutions and strategies, including risk mitigation
Manage and implement planning, authoring, and submission of high-quality briefing documents and clinical trial applications in the US and global regions
Direct point of contact with health authorities, lead and manage FDA/global health (ex-China) authority interactions/meetings for project responsibilities; prepare and submit responses to queries
Drive adherence to global regulatory guidelines relevant for the development of oncology products; author, review, and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals
Partner and work closely with regulatory personnel in China to deliver on study and/or program level objectives involving the China territory
Monitor global regulatory guidelines and anticipate trends that may impact the regulatory environment to strengthen product development plan(s) and adopt regulatory strategies in a timely manner
Additional responsibilities may be required
What Knowledge & Experience you'll bring to us...
A minimum of a Bachelor's and/or degree in biological, pharmaceutical, chemical or engineering sciences with 15+ years of experience, at least 10+ years in regulatory affairs, or an equivalent combination of experience is required
Advanced scientific degree in the sciences, or health-related field is preferred
Knowledge of FDA and EU regulations is required. Experience in filing regulatory submissions from early development to pre and post-approval submissions and product lifecycle management.
Proven leader with strong managerial experience with a track record of hiring, managing and developing team members
Experience with regulations or product development in oncology is strongly preferred.
Experience working in global environment strongly preferred
Direct experience managing NDAs/BLAs through FDA review and approval
Strong knowledge of eCTD elements and structure and regulatory writing skills
Demonstrated knowledge of regulatory requirements in the design and conduct of clinical trials, including preparation of regulatory submissions
Experience directly writing submission documents that support clinical trials, marketing applications, and lifecycle management is highly preferred
Behavioral skills to be successful...
Problem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
Emotional intelligence, curiosity, and a knack to figure out a way to build something better
Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.
Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.
Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.
What we have for you!
Competitive Base Salary, Bonus, and Equity Plans
Unlimited Vacation and 10 Sick Days Annually
Excellent Medical, Dental, and Vision Coverage
401K with Company Matching
and much more!
The base pay offered will take into account internal equity and also may vary depending on the candidate’s job-related knowledge, skills, experience, and location among other factors. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.
Disclaimer
Nuvation Bio, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.
This job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Note to all external Recruiters & Staffing Agencies All of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.
About the job
Executive Director - Regulatory Affairs
To see similar active jobs please follow this link: Remote Management jobs
Who we are…
Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer.
What you’ll be doing
The Executive Director, Regulatory Affairs reports directly to the Chief Regulatory Officer and will be responsible for providing global regulatory leadership and direction to support the development, registration, and life-cycle management of innovative programs for Nuvation Bio. The Executive Director, Regulatory Affairs will oversee the content and preparation of all regulatory documents and submissions related to applicable programs. Additionally, this individual will mentor junior members of the regulatory team and anticipate and plan for changes in FDA, EU, and other relevant, global regulations and requirements.
You will be responsible for…
Provide global regulatory leadership to support development of multiple, innovative therapies for oncology programs
Lead and develop a high performing regulatory team supporting their career devel
Partner with key team members to develop strategies to advance program from IND through pivotal studies and registration, leveraging a deep understanding of the landscape of oncology development and commercialization
Partner and work closely with Nonclinical, CMC, Quality, and Clinical to ensure achievement of submission deadlines, and obtain timely approvals of clinical trial applications
Drive the planning and implementation of meetings with regulatory authorities and effectively represent Nuvation Bio with regulatory interactions
Understand and interpret complex scientific issues for assigned projects as they relate to regulatory requirements and strategy for assigned projects, and provide knowledge and expertise to guide the team in appropriate regulatory strategy
Proactively identify regulatory issues; offer creative solutions and strategies, including risk mitigation
Manage and implement planning, authoring, and submission of high-quality briefing documents and clinical trial applications in the US and global regions
Direct point of contact with health authorities, lead and manage FDA/global health (ex-China) authority interactions/meetings for project responsibilities; prepare and submit responses to queries
Drive adherence to global regulatory guidelines relevant for the development of oncology products; author, review, and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals
Partner and work closely with regulatory personnel in China to deliver on study and/or program level objectives involving the China territory
Monitor global regulatory guidelines and anticipate trends that may impact the regulatory environment to strengthen product development plan(s) and adopt regulatory strategies in a timely manner
Additional responsibilities may be required
What Knowledge & Experience you'll bring to us...
A minimum of a Bachelor's and/or degree in biological, pharmaceutical, chemical or engineering sciences with 15+ years of experience, at least 10+ years in regulatory affairs, or an equivalent combination of experience is required
Advanced scientific degree in the sciences, or health-related field is preferred
Knowledge of FDA and EU regulations is required. Experience in filing regulatory submissions from early development to pre and post-approval submissions and product lifecycle management.
Proven leader with strong managerial experience with a track record of hiring, managing and developing team members
Experience with regulations or product development in oncology is strongly preferred.
Experience working in global environment strongly preferred
Direct experience managing NDAs/BLAs through FDA review and approval
Strong knowledge of eCTD elements and structure and regulatory writing skills
Demonstrated knowledge of regulatory requirements in the design and conduct of clinical trials, including preparation of regulatory submissions
Experience directly writing submission documents that support clinical trials, marketing applications, and lifecycle management is highly preferred
Behavioral skills to be successful...
Problem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
Emotional intelligence, curiosity, and a knack to figure out a way to build something better
Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.
Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.
Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.
What we have for you!
Competitive Base Salary, Bonus, and Equity Plans
Unlimited Vacation and 10 Sick Days Annually
Excellent Medical, Dental, and Vision Coverage
401K with Company Matching
and much more!
The base pay offered will take into account internal equity and also may vary depending on the candidate’s job-related knowledge, skills, experience, and location among other factors. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.
Disclaimer
Nuvation Bio, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.
This job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Note to all external Recruiters & Staffing Agencies All of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.