Associate Manager Regulatory Submissions
View: 107
Update day: 11-06-2024
Location: Maidenhead South East
Category: Printing / Publishing Science Labor Pharmaceutical / Chemical / Biotech
Industry: Pharmaceutical Biotechnology
Job content
Job Overview:
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.
Deadline: 26-07-2024
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