Regulatory Affairs Senior Associate works with the Regulatory Affairs Associate Director to ensure that the activities that take place and the documentation that is produced within the cGMP environment comply with the necessary regulations and guidelines governing the development, licensure and marketing of drugs and/or biologics to fulfil project objectives.
The Regulatory Affairs Senior Associate reports to the Regulatory Affairs Associate Director.
- Conduct relevant checks to support regulatory cmc queries from various groups across site,
- Process GMP documentation to support global submissions.
- Responsible for the timely sourcing and or authoring of documentation to support regulatory submissions worldwide
- Assist in the preparation for interactions with global regulatory authorities
- Represent regulatory cmc at relevant site meetings
- Participate in global teams as regulatory cmc representative for project specific discussions
- Responsible for timely sourcing and or authoring of documentation to support regulatory filings and/or correspondence with Regulatory bodies.
- Proactively identifying issues and suggesting appropriate strategies to mitigate risks.
- Ensure consistent and appropriate communication within the department and with other functional areas.
- Interact with global Regulatory partners, internal cross functional teams, and consultants.
- Participate in cross-functional project teams and work effectively with multiple disciplines and personalities
- 5+ years' experience in a cGMP regulated environment, with exhibited knowledge or proficiency in CMC Regulatory Affairs or a related function.
- Candidate should demonstrate initiative and have the ability to work both independently and collaboratively in a team structure.
- Demonstrated effective problem solving, strong understanding of regulatory affairs submission and management skills and the ability to prioritize multiple tasks are also required
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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