ManagerSenior Manager Regulatory Affairs CMC
ManagerSenior Manager Regulatory Affairs CMC
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$ 100000 - 170000
1 Vacancy
Job Description
Ventyx is a clinicalstage biopharmaceutical company focused on developing innovative oral medicines for patients living with autoimmune and inflammatory disorders. We believe our ability to efficiently discover and develop differentiated drug candidates will allow us to address important unmet medical needs with novel oral therapies that can shift inflammation and immunology markets from injectable to oral . Our current pipeline includes internally discovered clinical programs targeting NLRP3 S1P1R and TYK2 positioning us to become a leader in the development of oral immunology therapies for peripheral and neuroinflammatory diseases.
The Opportunity: Manager/Senior Manager Regulatory Affairs CMC:
The Manager Regulatory Affairs CMC will be responsible for CMC regulatory submissions including US IND applications amendments to INDs IMPDs DSURs and annual reports ensuring submissions are high quality and submitted on time. This position will collaborate productively with functional areas providing submission relevant documentation for regulatory dossiers and ensure documents and submissions comply with regulatory and company guidances.
What You Will Contribute:
- Develop communicate and manage project timelines for CMC regulatory submissions correspondence and commitments to Health Authorities
- Coordinate and contribute to Module 3 authoring manage the review QC formatting and approval of INDs IMPDs DSURs and annual reports correspondence and briefing documents ensuring timelines and standards are met
- Build timelines and content plans for Module 3 submissions
- Support the preparation of responses to questions and comments from regulatory agencies
- Actively contribute and participate as a member of Regulatory Affairs team maintaining effective interactions within the team and with other functional areas within the organization
- Provide change control assessments and tracking as needed
- Provide preparation and planning support for internal meetings
- Keep abreast of regulatory procedures and changes and be a change agent for improvements standardization risk mitigation and best practices.
- Additional duties assigned as needed
What We Seek:
- At least 4 years of relevant Regulatory Affairs experience in the biotech/pharmaceutical industry required
- Bachelors degree in scientific discipline
- Excellent attention to detail and organizational skills including the ability to prioritize workload
- Strong working knowledge of ICH GMP IRB/IEC and local regulatory authority drug research & development regulations
- Demonstrated ability to learn and prioritize multiple responsibilities independently remove barriers and drive projects to completion
- Strong oral and written scientific communication skills
- Ability to strike a balance between independent work and team interaction within a crossfunctional team
- Welldeveloped interpersonal skills with experience collaborating with influencing people and building strong positive relationships
- Proficiency in Microsoft Office and other productivity tools with an aptitude to learn new software and systems
- Ability to travel as necessary
What We Provide to You:
- The opportunity to make a difference in peoples lives impacted by autoimmune and inflammatory diseases.
- Participate in a team of life science professionals who value science data high work ethic and a meritocracy; access to all levels of the organization to get work done with a sense of urgency.
- Competitive compensation and a comprehensive benefit package including stock options.
The anticipated annual base salary range for this role is $100000 to $170000. Final compensation depends on multiple factors including but not limited to relevant experience skillset depth and breadth of knowledge internal equity company needs and market factors. Ventyx is a rapidly growing biotech company that offers competitive wages and benefits package including medical dental vision LTD time off a retirement plan and other voluntary benefits for employees.
Ventyx is an equal opportunity employer and strives to maintain a work environment in which all individuals are treated with respect and dignity. Qualified applicants will receive consideration for employment without regard to race age ethnicity or national origin color religion sex (including pregnancy childbirth breastfeeding or related medical conditions) gender identity sexual orientation disability or medical condition (including genetic information or characteristics or those of a family member) military service or veteran status or any other characteristic protected by local state or federal laws rules or regulations.
Notice to Recruiters and Agencies:
The Human Resources team manages the recruitment and employment process for Ventyx Biosciences. To protect the interest of all parties involved Ventyx Biosciences does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation search firms staffing or recruiting agencies or feebased referral services. The submission of referrals or resumes by anyone other than a candidate directly to Ventyx Biosciences employees is strictly prohibited. Unsolicited referrals and resumes sent to Ventyx are deemed gratuitous and do not obligate Ventyx to pay fees should we hire from those resumes. Recruiters are requested NOT to contact or present candidates directly to our hiring managers or employees. Please direct all inquiries to .
Required Experience:
Senior Manager
Employment Type
Full-Time
