About Us:
At BlossomHill Therapeutics, we are on a mission to redefine precision medicine and make a leap forward in life expectancy and quality of life for patients.
Our cancer therapies are exquisitely designed to be potent against cancer drivers and aim to address cancer's resistance to treatment from multiple angles. Our autoimmune programs seek to tackle difficult challenges to deliver life-changing therapies for patients.
Driven by a desire to transcend incremental improvements to existing drugs, we approach drug design from the ground up. Combining human intelligence, creative thinking, and proven drug design expertise, we are dedicated to developing small-molecule masterpieces that have the potential to set new standards for cancer and autoimmune disease treatment.
Position Summary:
Reporting to the Senior Director of Regulatory Affairs, the Manager/Senior Manager, Regulatory Affairs will be responsible for strategic and administrative aspects of regulatory submissions and life cycle management, ensuring that submissions are in support of company goals, of highest quality, and delivered on-time. Emphasis will be on collaborative strategic planning, management, and execution on all aspects of regulatory affairs in a dynamic workplace. This position is onsite.
Key Responsibilities:
- Actively participate as a member of the Regulatory Affairs team and on cross-functional product development teams, as needed.
- Contribute to developing and implementing regulatory strategies for submissions from early research and development (R&D) through commercialization.
- Support the compilation, review, and/or filing of INDs, CTAs, briefing documents, and maintenance of development and approved applications.
- Coordinate and contribute to the authoring of submission documents such as DSURs, annual reports, and amendments, as needed.
- Develop and manage project timelines for regulatory submissions.
- Maintain effective interactions with all contributors and Regulatory Affairs management, to ensure timely delivery of documents for regulatory submissions.
- Provide regulatory assistance and review of clinical study documentation, including review of clinical protocols, informed consent forms, clinical study recruitment materials, and essential document packages.
- Track submissions, correspondence, and commitments with health authorities.
- Provide guidance to project teams to ensure regulatory documentation is complete, accurate, of high quality and electronically functional.
- Write and/or maintain standard operating procedures, department working practices, templates and style guides, as appropriate.
Qualifications:
- Bachelor's or M.S./Ph.D. degree in scientific area.
- Minimum of 7 years' experience with a Bachelor's or 5 years' experience with M.S./Ph.D. of relevant Regulatory Affairs experience in a biotech/pharmaceutical setting.
- Equivalent combination of relevant education and applicable job experience may be considered.
- Experience and understanding of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP) requirements, and FDA regulations.
- Experience and knowledge in the preparation of regulatory submissions, ie, US IND sequences.
- Ability to work both independently with direction and within project teams and see all projects through to their completion.
- Excellent written and oral communication skills.
- Strong organizational skills, including the ability to prioritize workload.
- Excellent problem-solving, analytical thinking skills.
- Strong interpersonal skills and the ability to deal effectively with other people/departments.
- Strong attention to detail.
- Ability to meet deadlines and perform multiple tasks in a fast-paced setting.
- Strong software knowledge and skills: Windows, MS Office (Outlook, advanced level MS Word, Excel, PowerPoint, Adobe PDF), SmartSheet.
- Additional experience with Clinical Trial Authorizations (CTA) helpful.
- Experience interpreting and applying local regulations and guidance for drug development from early R&D through commercialization preferred.
- Electronic document management systems use (eg, Veeva) highly desired. Publishing experience and/or eCTD knowledge is desired.
AAP/EEO Statement:
The company provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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