Job Title: Global Submission Associate
About the jobThe Global Submission Associate coordinates lifecycle submissions for the global portfolio, working directly with key stakeholders, GRA focal points and publishing partners to ensure the submissions are prepared on-time and with high quality while meeting Health Authority (HA) specifications. Partners with Submission Managers and Submission Leads to support the publishing and delivery of complex submission plans. Accountable for 3rd party publishing interactions, training, QC and workload prioritization. The Global Submission Associate also provides publishing subject matter expertise to project/product teams and continuous improvement initiatives.
Main responsibilities:- Coordinate lifecycle submission requests for the global portfolio, working directly with key stakeholders, GRA focal points, local affiliates, and publishing partners to ensure the submissions are prepared on-time and with high quality while meeting HA and regional requirements into global submissions.
- Partner with GBU and regional submission platforms to achieve and execute GSS plans and delivery, utilizing content re-use strategies and applying technical expertise
- Provide guidance to project teams on developing submission structure strategies in accordance with HA and ICH regulations, guidelines and specifications
- Collaborate and support third-party vendors as needed to support submission efficiency and overall success
- Prepare, compile and review regional submission documentation to regulatory health authorities according to ICH / eCTD format and submission ready health authority standards, as well as Sanofi standards
- Ensure end-to-end process adherence for routine compliance submissions
- Perform quality control checks for submission publishing, understanding and addressing validation criteria in detail, and troubleshooting
- Assist in improvement efforts of publishing processes and contribute to review and updates of quality documents
- Identify and raise submission technical issues in timely manner to ensure that resolutions are realized, enabled and executed to deliver according to planned submission filing dates
- Maintain knowledge of regulatory requirements for document and submission assembly and publishing across various submission regions on a continuous basis.
About YouBasic Qualifications:
- Bachelor's degree in regulatory affairs, sciences, or related areas. Other fields (e.g., business administration, economics, law) will be considered if the candidate has publishing experience.
- 3+ years of experience in the pharmaceutical industry, with direct regulatory affairs experience.
- Proficiency in eCTD publishing tools and platforms.
- Knowledge of regulatory submission requirements for at least one of: US, Canada, or EU.
- Dossier assembly and technical standards (eCTD structure, modules).
Preferred Qualifications:
- Working knowledge of drug laws, regulations and guidelines is essential.
- Proficiency in publishing and technical review of Module 4 and 5 datasets is essential.
- Understanding of global regulatory requirements, global submission processes (re. EMA work sharing) and drug development process.
- Familiarity with document management systems (e.g., Veeva), RIM systems and DMS systems.
- Maintain independent abilities to learn quickly and adapt to new technologies/environments.
- Self-starter, who motivates and negotiates with an agile and positive approach.
- Ability to implement and manage global regulatory technology solutions to streamline processes.
- Ability to identify critical technical issues and propose creative and achievable solutions through technical expertise and troubleshooting.
- Strong attention to detail and accuracy.
- Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization.
- Ability to operate with agility in a dynamic global environment.
- Ability to maintain discretion and confidentiality about sensitive data.
- Ability to communicate and collaborate on many levels, including issue escalation to GRA leadership.
- Ability to work across cultures
Why Choose Us- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
The salary range for this position is:
$75.000,00 - $108.333,33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
