- Provide input to global regulatory submission strategy, preparing regulatory submission documents, and reviewing regulatory submissions for completeness and quality in global accordance with regulatory agency requirements, standards, and corporate practices
- Previous experience with compilation and filing of INDs, IND amendments, NDA, NDA supplements and CTAs.
- Represent the regulatory affairs function on project teams to provide regulatory support and advice
- Interact with corporate partners and contracted vendors regarding various regulatory matters
- Provide support for regulatory interactions, including meetings and teleconferences with global health authorities
- Show good judgment to determine when to escalate problems to his/her superior
- Draft and/or modify applicable SOPs and/or other written practices relating to the regulatory affairs function
- Bachelor's degree, preferably in a scientific discipline
- 6+ years' experience in the pharmaceutical industry
- 4+ years' experience in regulatory affairs
- Strong working knowledge of U.S. and international regulatory requirements for oncology drugs
- Excellent oral and written communication skills
- Ability to collaborate effectively with key stakeholders and coordinate and lead activities cross-functionally
- Patients – We are committed to improving the lives of patients living with cancer. They are the driving force behind everything we do.
- Accountability – We demand accountability for our actions, behaviors, and performance. We recognize our duty to maintain a culture that embraces the uniqueness of our people and finds strength in our differences.
- Transparency – We strive to provide full visibility to internal and external stakeholders for a complete picture of what we are doing and why.
- Honesty and Integrity – Trust and mutual respect are essential aspects of our culture. We act with honesty and integrity in all facets of our business, and this serves as the foundation of our work and interactions with others.
- Stewardship – We are respectful of the resources entrusted to us by the investment community. We act thoughtfully and allocate resources responsibly in seeking to create value for our shareholders.
- Lead from where you are – regardless of role or level, we motivate each other to achieve common goals.
- Drive business results – we navigate forward with our eye on the highest priorities.
- Partner and collaborate – we cultivate relationships and value ideas, regardless of where they are coming from, to achieve more together.
- Continuously evolve and improve – we try, we learn, we revise and try again.
- Non-accrual paid time off
- Summer vacation bonus
- Global, company-wide summer and winter shutdowns
- An annual lifestyle allowance
- Monthly cell phone stipend
- Internal rewards and recognition program
- Medical, Dental, and Vision Insurance
- 401(k) retirement plan with company match
- Life and Supplemental life insurance for family
- Short and Long Term Disability insurance
- ESPP offering
- Health savings account with company contribution
- Flexible spending account for either health care and/or dependent care.
- Family planning benefit
- Generous parental leave
- [if applicable] Car allowance
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Manager, Regulatory Affairs - Waltham, United States - Deciphera Pharmaceuticals
Description
Job Description
Job DescriptionCompany DescriptionDeciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.
Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK (ripretinib) is Deciphera's switch control inhibitor developed for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United States, and the United Kingdom. We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China. In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116.
See here for more details on our portfolio.
Job DescriptionThe Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development. In this role, the Manager of Regulatory Affairs will support the regulatory lead on program related projects and be responsible for interacting with multiple functions to manage high quality regulatory submissions.
This role is responsible for the supporting regulatory submissions such as: investigational new drug applications (INDs), clinical trial applications (CTAs) and components of marketing applications as well as post-approval submissions and life-cycle maintenance activities.
Key Responsibilities:
We are proud to be Great Place to Work Certified 2023 and rank #25 on Fortune's Best Places to Work Small and Midsized Biotech Companies in 2023. Find more details about our award-winning culture here.
We offer an outstanding culture and opportunity for personal and professional growth based on our "PATHS" Core Values:
"How" we work together and the behaviors that we show up with each day are critical to maintaining our positive culture. Our behavioral expectations align with our values to elevate and drive individual and team performance:
Deciphera offers a comprehensive benefits package that includes but is not limited to the following:
Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland.
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.
