- 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
-
Regulatory Affairs
3 days ago
Third Rock Ventures Waltham, United StatesThe position will provide regulatory expertise and leadership to assure that the company meets its business objectives while complying with the regulatory framework by taking into account applicable laws, regulations and guidance documents. The incumbent will be responsible for i ...
-
Regulatory Affairs
1 week ago
Third Rock Ventures Waltham, United StatesThe position will provide regulatory expertise and leadership to assure that the company meets its business objectives while complying with the regulatory framework by taking into account applicable laws, regulations and guidance documents. The incumbent will be responsible for i ...
-
VP, Regulatory Affairs
4 weeks ago
Vigil Neuroscience, Inc. Watertown, United StatesJob Description · Job DescriptionVigil Neuroscience is the world's first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain's immune system. ...
-
Director, Regulatory Affairs
1 week ago
Dyne Therapeutics Waltham, United StatesCompany Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide th ...
-
Regulatory Affairs Specialist
2 weeks ago
Philips Cambridge, United States Full timeJOB DESCRIPTION Job Title · Regulatory Affairs Specialist Job Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards cre ...
-
Regulatory Affairs Specialist
3 weeks ago
Philips Cambridge, United States Full timeJOB DESCRIPTION Job Title · Regulatory Affairs Specialist Job Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards cre ...
-
Director, Regulatory Affairs
6 days ago
Apellis Waltham, United StatesJob Description · Job DescriptionPosition Summary: · The Director, Regulatory Affairs will be responsible for ensuring the development and delivery of science-based, solution-oriented, and globally aligned regulatory strategies for accountable program(s). · Key Responsibilities ...
-
Manager, Regulatory Affairs
3 weeks ago
Deciphera Pharmaceuticals Waltham, United StatesCompany Description · Deciphera 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 ...
-
Director, Regulatory Affairs
5 days ago
Relay Therapeutics Cambridge, United StatesThe Opportunity: · We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will have the opportunity to define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline. Yo ...
-
Regulatory Affairs Specialist
2 weeks ago
Philips Cambridge, United States Full timeJob Title · Regulatory Affairs SpecialistJob Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and faire ...
-
VP Regulatory Affairs
1 week ago
Korro Bio, Inc. Cambridge, United StatesKorro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body's n ...
-
Regulatory Affairs Manager
1 week ago
Katalyst HealthCares & Life Sciences Cambridge, United StatesResponsibilities: · However, they will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs · This individual will prepare, compile, and submit CT/IND/MAA I NOA, manage and implement label review, translation requirements, fee requiremen ...
-
Regulatory Affairs Manager
3 weeks ago
Katalyst HealthCares & Life Sciences Cambridge, United StatesResponsibilities: However, they will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs · This individual will prepare, compile, and submit CT/IND/MAA I NOA, manage and implement label review, translation requirements, fee requirements ...
-
Director, CMC Regulatory Affairs
4 weeks ago
Alkermes Watertown, United StatesJob Description · Overview: · Great Science. Deep Compassion. Real Impact. · Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, and addiction. · We are inspired by the cour ...
-
Senior Director Regulatory Affairs
2 weeks ago
RBW Consulting Cambridge, United StatesRBW is partnering with an innovative late clinical-stage, oncology Biotech (140 FTE) in their urgent and business-critical search for a new Senior Director, Regulatory Affairs. Our client is focused on discovering and developing precision medicines for the treatment of autoimmune ...
-
Senior Director Regulatory Affairs
1 week ago
FRESENIUS MEDICAL CENTER Watertown, United StatesPOSITION FEATURES: · This is a remote position with 25% travel · PURPOSE AND SCOPE: · Manages a field team of regulatory compliance employees and provides regulatory expertise through leadership, collaboration, development, management, monitoring, analyzing, and evaluating the im ...
-
Manager, Regulatory Affairs
1 week ago
Takeda Pharmaceutical Company Ltd Lexington, MA, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I sub ...
-
Head of Clinical and Regulatory Affairs
3 weeks ago
Siemens Corporation Newton, United StatesDo you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. · We offer you a flexible and dynamic environm ...
-
Senior Director Regulatory Affairs
1 week ago
Fresenius Kidney Care Waltham, United StatesSenior Director Regulatory Affairs page is loaded · Senior Director Regulatory Affairs · Apply · locations · Waltham, MA, USA · time type · Full time · posted on · Posted 3 Days Ago · job requisition id · R · This is a remote position with 25% travel · PURPOSE AND SCOP ...
-
Manager Regulatory Affairs
3 weeks ago
Deciphera Pharmaceuticals Waltham, United StatesJob Description · The 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 interacti ...
Manager, Regulatory Affairs - Watertown, United States - Deciphera Pharmaceuticals
Description
Company 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 Description
The 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:
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.