Manager, Regulatory Submissions and Labeling Operations (Madison, New Jersey, United States, 07940) bei Derma­tology beyond the skin

Application deadline:  
Location: Madison 07940, New Jersey, United States 
Contract type: Permanent 
Job ID: 3502 

Your Role

This position is overall accountable and responsible for project managing compilation and publishing of US submissions and supporting labeling activities for the US. It involves maintaining the overview of all US submissions to ensure deliverables across given portfolios.

Your Responsibilities

Submission Management: 
•    Act as Project Manager of tasks related to compilation and publish-ing of US Regulatory submission
•    Creating and managing cross-functional timelines for US submis-sions with consideration of key interdependencies
•    Managing the timely delivery of compliant US submissions
•    Responsible for technical interactions with FDA, i.e. gateways, vali-dation issues and similar
•    Participating in Global Regulatory Team as US Submission Manager (as required) - Providing overview/status of all US submission activi-ties relevant to the team and presenting and highlighting the dossi-er strategy and relevant submission intelligence/approach, risks and solutions as relevant.
•    Responsible for ensuring processes related to eCTD readiness and authoring submission documentation are adhered to
•    Responsible for intelligence related to eCTD readiness and GxP, Good Documentation practices
•    Responsible for handling deviations relating to documentation practices within the scope of GRA

Labeling: 
•    Responsible for developing and maintaining US Prescribing Infor-mation (USPI), Patient Package Inserts (PPIs), Medication Guides (MGs), Instructions for Use (IFUs) and labeling artwork as applicable.
•    Provide input to submissions and launch readiness with regards to the labelling components.
•    Collaborate with the US Regulatory Strategists and cross-functional teams to develop and maintain accurate and FDA compliant label-ing content.
•    Assist in audits and/or inspections related to labeling.

General: 
•    Act as Operational lead for assigned projects. 
•    Provide regulatory intelligence on eSubmission requirements and strategy.

•  Build and maintain knowledge, incl. monitor and assess new and re-vised regulatory legislation and guidelines relevant to the roles and responsibilities of the position. 

Your Qualifications

•    BA/BSc Degree in scientific discipline required; Master’s Degree preferred 
•    3+ years’ experience working in Pharma/Biotech Regulatory Affairs and within different areas (CMC, Labelling, Clinical, Submission Management, Local RA) 
•    3+ years’ experience working within a Submission Management func-tion, managing complex US submissions with in-depth knowledge of regulatory requirements for US
•    Understanding of CMC, Labelling, Clinical within pre-approval and/or post-approval activities
•    Solid knowledge and experience within Submission Management and US FDA requirements in relation to dossier management, submission processes and labeling activities. 
•    Ability to collaborate and communicate well with internal stakeholders, with an understanding of cultural differences and perspectives. You will have a strong drive and ability to execute according to plans as well as a continuous improvement mindset.
•    Project Management certification or experience preferred

The base salary range for this position is $115,000 - $175,000 per year. The base salary range represents the anticipated low and high of the LEO Pharma range for this position. Salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. In addition, some positions may include eligibility to earn commissions/bonus based on company and / or individual performance.

Beyond the skin

Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact.  Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet. 
 
LEO Pharma Inc. is an Equal Opportunity/Affirmative Action Employer. At LEO Pharma, we believe that our different perspectives, backgrounds, and attitudes are what enable us to make the best decisions, foster an inclusive culture, and meet the needs of the market we operate in. Therefore, we encourage you to apply for the position if you are excited about the role – even if you don’t meet every single requirement listed, you might be just the pioneer we are looking for. With this in mind, applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. We believe in flexibility in all aspects - also when it comes to supporting our employees' diverse needs, hence, we offer hybrid work opportunities whenever possible.

For certain positions, LEO Pharma might complete a background check conducted by a third party.

LEO Pharma Inc. seeks information for job applications from candidates in the U.S. through only the following channels:
•    the LEO Pharma Inc. website and Halogen Talent Acquisition, powered by Jobvite
•    via email to/from addresses using only the LEO Pharma domain of "@leo-pharma.com"
•    screening and interaction by telephone and through the Microsoft Teams platform.
Please note:
•    LEO Pharma does not use Google Hangouts, Zoom or any other platform for any recruitment-related activities.
•    Disregard any solicitation or request for information related to job applications with LEO Pharma via any other means and/or using email addresses with any other domain.
•    LEO Pharma will never ask candidates to make any type of personal financial investment related to gaining employment with the company.
 

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