Manager/Sr. Manager, Regulatory Affairs
4 weeks ago
The Manager/Sr. Manager, Regulatory Affairs (RA) will be responsible for operational aspects of global regulatory submissions, ensuring submissions are high quality and submitted on time. Additional responsibilities include tracking and archiving regulatory submissions and health authority correspondence. This position will collaborate productively with all functional areas providing submission relevant documentation for regulatory dossiers, and ensure documents and submissions comply with regulatory and company guidance.
What You Will Contribute:
- May author and prepare global regulatory documentation and electronic submissions, ensuring timelines and standards are met.
- Develop, communicate, and manage project timelines for regulatory submissions, correspondence, and commitments to Health Authorities.
- Manage the compilation, review, approval, and filing of INDs, CTAs, correspondence, and briefing documents ensuring timelines and standards are met.
- Proactively provide regulatory assistance and review of clinical study documentation, including clinical protocols, and informed consent documents.
- Support the preparation of responses to questions and comments from regulatory agencies.
- Maintenance of approved submissions.
- Coordinate and contribute to the authoring of submission documents such as DSURs, annual reports, and amendments, as applicable.
- 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 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 applicable.
- 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 3 years of relevant Regulatory Affairs experience in the biotech/pharmaceutical industry required.
- BS/BA degree in a life sciences, clinical management, or related field required.
- Excellent organizational skills, including the ability to prioritize workload.
- Strong working knowledge of FDA, ICH, GCP, 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, be a team player in a cross-functional team.
- Well-developed interpersonal skills, with experience in interacting with and influencing people and building strong positive relationships.
- Proficiency in Microsoft Office and other productivity tools with an aptitude to learn new software and systems.
What We Provide to You:
- The opportunity to make a difference in people’s 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 $90,000 to $140,000. 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 fee-based 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 careers@ventyxbio.com.
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