Regulatory Submissions Planner -Regulatory Operations - United Kingdom
Want to know company name or location? Company managed [?]
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career
- We have an exciting opportunity for a Regulatory Submissions Planner, Regulatory Operations, to join our team.
- The Regulatory Submissions Planner will work within the company Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regulatory Affairs Operations Europe.
- The Regulatory Submissions Planner supports the regulatory submission creation and the registration tracking of the company regulatory submission targets from a regulatory operational perspective.
- As a member of cross-functional team and for the assigned products, her/she manages all operational aspects from submission planning, document retrieval, to submission creation and delivery to Health Authorities.
- This position requires a high level expertise and knowledge of the European regulatory landscape, its registration procedures and a thorough understanding of the technical requirements for dossiers (e.g.: eCTD). Regulatory knowledge of the wider region (i.e.: non EU CES, CIS, Middle East and Africa) will be an advantage for this role.
- Planning, coordinating and reviewing regulatory submissions with release to Country Operations teams and/or submission to Health Authorities.
- Responsible for developing and maintaining the regulatory submission plan for the assigned projects/products and maintaining the related project milestones.
- Lead Submission Planning Management Teams (SPMT) meetings
- Work closely with the corresponding Planner based in the HQ(US) on assigned products/projects
- Drive the submission assembly and delivery process with the Global Submission Publishing team to ensure timely assembly, publishing and archival of assigned products/submissions as per the agreed timelines.
- Responsible for accessing and maintaining the regulatory systems and databases to fulfil daily functions.
- Assist in identifying opportunities to continually improve the efficiency of the submission process and participate in small-scale process improvement projects.
- Maintain knowledge on the European and non-European procedures (on internal and external guidelines and standards).
Bachelors degree in a Life Science related discipline.
Experience and Skills:
- At least 2 years’ experience in the regulatory operations area, regulatory affairs will be an asset.
- Able to multitask with proven project management capabilities including managing dynamic timelines, interacting and negotiating with others, collaboration skill and excellent follow-up ability
- Thorough knowledge of regulatory guidelines and procedures within the European Region is required and knowledge of submissions in the wider region (CIS states and Africa) is preferable
- Excellent communication skills to manage interactions with colleagues within and outside the department to co-ordinate the regulatory submission for a timely delivery
- Capability to keep overview in the complexity of planning, managing, tracking, assembling and delivering of regulatory content, to meet regulatory strategy, regulatory compliance and informational needs for internal and external customers.
- Ability to handle time pressure and the consequence of any delay in timely submissions.
- Affinity to work with complex IT systems.
- Our employees are the key to our company’s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
Job Segment: Regulatory Affairs, Operations Manager, Law, Compliance, Legal, Operations