The Associate Manager Regulatory Submissions is responsible for the timely preparation of submissions to Regulatory Authorities in support of investigational and marketed products. Interacts with Regulatory Authorities and with clients to support regulatory activities. Proactively interacts with other Labcorp Drug Development groups and with clients to provide guidance regarding Regulatory Authority requirements and project timelines and requirements. Working with minimal supervision, it is the responsibility of the Associate Manager to ensure that documents are prepared to the required standards by maintaining awareness of current regulatory standards related to drug submissions and clinical research, and be responsible for providing general Regulatory Authority submissions advice to client companies and/or the Labcorp Drug Development project team. May have supervisory responsibilities. May take on lead role primarily on a regional level for medium to larger studies but can hold a global lead role depending upon studies but can hold a global lead role depending upon experience level.

Your main responsibilities will include but not be restricted to:

• Prepare study documentation such as the core EudraCT Form (Annex I, II & III) and cover letter.
• Prepare routine submissions filed to Regulatory Authorities (e.g. INDs/CTAs and NDAs/MAAs/CTDs). Will take ownership for specific pieces of work and may be the Regulatory Submissions lead for projects.
• Review/summarize scientific/research documents in preparation for submission to Regulatory Authorities.
• Assist in the coordination, collection and organization of data and information required by Regulatory Authorities.
• Interact with the Publishing group, Copy Center or equivalent as necessary for the production of submissions.
• Responsible for maintaining awareness of regulatory legislation, guidance and practice pertaining to Regulatory Authority submissions.
• Assure compliance with regulatory requirements in relation to assigned projects.
• Participate independently in client meetings and proactively liaise with clients on regulatory submission issues.
• May take regional lead role primarily for small - medium/more complex projects but may also take global role as applicable on small / less complex studies.
• Mentor and coach other GRS team members.
• Participate in training of personnel.
• Provide regulatory submissions advice to external and internal teams.
• Assist in providing timely status on projects.
• May represent Regulatory Submissions in new proposal opportunities.
• Work on special regulatory projects as assigned .

Education/Qualifications:

• Candidates are recommended to have a Bachelor's Degree in Life Sciences or equivalent.

Experience:

• Candidates are required to have a minimum of four years of experience in the Pharmaceutical/CRO industry in Regulatory Affairs or Drug Development.