The candidate will be leading the regulatory strategies for biologic products and combination products for the product portfolio assigned.
In this role, a typical day might include the following :
- Responsible for CMC / CP product development activities to lead the regulatory standpoint during early phase, development, submissions and post market requirements
- Participate in IOPS cross-functional meetings for program-specific discussions, connect the dots across IOPS, proactively identify CMC / CP regulatory issues and develop appropriate strategies to mitigate or fix them, independently finds alternative solutions, acquires buy-in from organization;
Ensure appropriate communications between IOPS and global RA in a timely manner
Participate in global RA meetings, provide regulatory interpretation, position, and strategies to support CMC / CP prduct development activities.
Proactively initiating and managing communications between Global RA and IOPS to ensure they happen in a timely manner
- Critically review and provide strategic feedback on regulatory filing documents (e.g. pre-INDs, INDs, IMPDs, BLAs, MAAs, BPDRs, annual reports, DSURs, amendments, supplements, scientific advice) to facilitate and expedite the development, licensure, and marketing of drugs and / or biologics.
- Identify strategic points required to be communicated for assigned programs and participating in preparation of challenging communications
- Manage the preparation for interaction with global regulatory authorities (e.g., meetings, IR responses, inspections)
- Perform the compliance activities of the portfolio to determine regulatory impact and associated submission requirement for clinical and commercial regulatory filings with country specific regulatory mentorship documents.
Mentor colleagues in difficult assessment discussions with SMEs or Senior Management.
This role may be for you if have :
- Need to have good understanding of current CMC / CP RA worldwide regulations.
- Proven track record of supporting biological product through development and approval is a distinct advantage
- Experience in delivering CMC / CP sections of marketing authorizations, clinical trial applications (CTA / IND) and post-approval submissions
- Experience in dealings with FDA and other regulatory authorities
- Established strategic thinking and strong problem-solving skills
- Strong communication and negotiation skills
- Ability to build collaboration and teamwork across cross functional
- teams.
To be considered for this opportunity we are looking for :
Bachelor’s degree in a relevant technical, scientific discipline required; advanced degree is an advantage and a minimum of 8 years (BS / BA) pharmaceutical / biotech experience including a minimum of 5 years of relevant CMC experience.
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