IDEAYA Biosciences
Senior director regulatory affairs
IDEAYA Biosciences, San Diego, California, United States, 92189
Position Summary:
IDEAYA Biosciences is seeking an experienced, motivated, outgoing leader to head Regulatory Affairs. This person will be responsible for development of US and rest of world regulatory strategy for IDEAYA’s oncology pipeline and to represent Regulatory Affairs on project teams. The individual must have knowledge of regulatory requirements in major regions (US, EU) with responsibility to form a global strategy, including in Asia; Develops and maintains communications with FDA and coordinates interaction with regulatory agencies worldwide. This position is based in our South San Francisco headquarters or San Diego office and required to be onsite four days per week per our company policy. What you'll do:
Develops regulatory strategic plans for project teams. Works with project teams to resolve complex project issues. Supports team interactions and alignment with partner. Utilizes expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained. Represent IDEAYA before regulatory authorities. Assists in the design and interpretation of results for Clinical Studies required for Regulatory Approvals. Responsible for filing of IND/CTA, NDA/BLA/MAA submissions. Sets strategy for submissions of product registration documents to health authorities worldwide. Interacts with other line functions in the preparation, review, and completion of documents for regulatory submissions. Responsible for keeping management team informed of regulatory status of programs and significant regulatory issues. Able to present and implement project related regulatory strategy with all Project Teams. Assures compliance with project team timelines and milestones. Effectively plans, organizes, and conducts (or supervises) formal meetings with regulatory agencies. Interacts with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications. Provides counsel, training, and interpretation of FDA’s and other regulatory authorities’ feedback, policies and guidelines to IDEAYA and assists as a liaison between IDEAYA and regulatory authorities. Provides interpretive analyses of complex regulatory guidance documents, regulations, or directives that influence IDEAYA’s products and operations. Advises personnel in other departments regarding their applicability and impact. Manages a team in Regulatory Affairs in support of filing of IND/CTA, NDA/BLA/MAA submissions. Has working knowledge of regulatory issues that pertain to CMC. Requirements:
Bachelor’s degree in a Life Sciences discipline or equivalent, with advanced degree (MS/PhD/PharmD) preferred. Minimum of ten (10) years of experience in clinical regulatory and high potential for leadership roles. Oncology experience preferred. Proven ability to develop and manage a high-performance regulatory team focused on accountability and meeting and exceeding expectations. Excellent track record for oncology product approvals in the US and EU preferred. Experience developing companion diagnostic regulatory strategy highly valued. Balance of strategic thinking and strong analytical skills with ability to execute. Experience with international regulatory submissions and an understanding of worldwide guidelines and regulations preferred. Essential Skills and Abilities:
Demonstrated excellence in regulatory liaison/strategy & effective negotiations with regulatory authorities. Strategic thinking, leadership skills, assertiveness, strong technical background, and project management skills as evidenced by past performance on drug development project teams. Able to analyze worldwide regulatory requirements to synthesize a global regulatory development strategy as evidenced by past regulatory experience. Excellent interpersonal skills. Excellent communication skills (verbal and written) as evidenced by a demonstrated ability to prepare complex documents / submissions and to give presentations. Ability to work independently. Ability to travel (approximately estimated 10% travel required). Salary:
$263,118 - $279,245 a year. Benefits:
At IDEAYA Biosciences, we care about our employees and strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health and well-being benefits. The expected salary range for this role that is based in our South San Francisco, California office and San Diego, California is: Senior Director level: $263,118 - $279,245 The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates’ experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process. The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company’s facilities, with partial work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.
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IDEAYA Biosciences is seeking an experienced, motivated, outgoing leader to head Regulatory Affairs. This person will be responsible for development of US and rest of world regulatory strategy for IDEAYA’s oncology pipeline and to represent Regulatory Affairs on project teams. The individual must have knowledge of regulatory requirements in major regions (US, EU) with responsibility to form a global strategy, including in Asia; Develops and maintains communications with FDA and coordinates interaction with regulatory agencies worldwide. This position is based in our South San Francisco headquarters or San Diego office and required to be onsite four days per week per our company policy. What you'll do:
Develops regulatory strategic plans for project teams. Works with project teams to resolve complex project issues. Supports team interactions and alignment with partner. Utilizes expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained. Represent IDEAYA before regulatory authorities. Assists in the design and interpretation of results for Clinical Studies required for Regulatory Approvals. Responsible for filing of IND/CTA, NDA/BLA/MAA submissions. Sets strategy for submissions of product registration documents to health authorities worldwide. Interacts with other line functions in the preparation, review, and completion of documents for regulatory submissions. Responsible for keeping management team informed of regulatory status of programs and significant regulatory issues. Able to present and implement project related regulatory strategy with all Project Teams. Assures compliance with project team timelines and milestones. Effectively plans, organizes, and conducts (or supervises) formal meetings with regulatory agencies. Interacts with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications. Provides counsel, training, and interpretation of FDA’s and other regulatory authorities’ feedback, policies and guidelines to IDEAYA and assists as a liaison between IDEAYA and regulatory authorities. Provides interpretive analyses of complex regulatory guidance documents, regulations, or directives that influence IDEAYA’s products and operations. Advises personnel in other departments regarding their applicability and impact. Manages a team in Regulatory Affairs in support of filing of IND/CTA, NDA/BLA/MAA submissions. Has working knowledge of regulatory issues that pertain to CMC. Requirements:
Bachelor’s degree in a Life Sciences discipline or equivalent, with advanced degree (MS/PhD/PharmD) preferred. Minimum of ten (10) years of experience in clinical regulatory and high potential for leadership roles. Oncology experience preferred. Proven ability to develop and manage a high-performance regulatory team focused on accountability and meeting and exceeding expectations. Excellent track record for oncology product approvals in the US and EU preferred. Experience developing companion diagnostic regulatory strategy highly valued. Balance of strategic thinking and strong analytical skills with ability to execute. Experience with international regulatory submissions and an understanding of worldwide guidelines and regulations preferred. Essential Skills and Abilities:
Demonstrated excellence in regulatory liaison/strategy & effective negotiations with regulatory authorities. Strategic thinking, leadership skills, assertiveness, strong technical background, and project management skills as evidenced by past performance on drug development project teams. Able to analyze worldwide regulatory requirements to synthesize a global regulatory development strategy as evidenced by past regulatory experience. Excellent interpersonal skills. Excellent communication skills (verbal and written) as evidenced by a demonstrated ability to prepare complex documents / submissions and to give presentations. Ability to work independently. Ability to travel (approximately estimated 10% travel required). Salary:
$263,118 - $279,245 a year. Benefits:
At IDEAYA Biosciences, we care about our employees and strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health and well-being benefits. The expected salary range for this role that is based in our South San Francisco, California office and San Diego, California is: Senior Director level: $263,118 - $279,245 The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates’ experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process. The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company’s facilities, with partial work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.
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