This position resides within Regulatory Affairs CMC and is accountable for new and marketed products support as it pertains to writing, compiling, and maintenance of the CMC technical section of Merial regulatory filings. The individual is expected to remain current with regard to regulations, guidelines and policies for the pharmaceutical/manufacturing areas and to assist in interpreting and counseling line organizations on the complex and evolving regulatory CMC requirements.
Major responsibilities include, but are not limited to, the following:
To all recruitment firms: Merial does not accept agency/search firm referrals for this posting, or other postings, without prior written permission from Merial Human Resources. Merial is not responsible for any fees related to unsolicited resumes.
- Coordinates compilation and reviews CMC data package for appropriate and complete documentation
- Communicates with internal and external customers to obtain required supporting documents data for compilation of the CMC dossier, supplements/variations, responses to authorities questions etc., maintaining timelines of projects
- Maintains Change Control Request process of Change Requests received in CMC
- Performs EMEA, U.S. and international regulatory research tasks as requested
- Assists the country registration managers/distributors/agents and provides them with technical regulatory support required for the PARTII/QUALITY section, appropriately adapted to the specific regulatory requirements
- May represent CMC on assigned New Product Development teams and related technical task forces such as: Research and prepare initial strategy for worldwide authorities; Support transfer of procedures to manufacturing
- May provide regulatory CMC expertise during negotiations and interactions with regulatory agencies
- Maintains an awareness of global regulatory and Pharmaceutical issues to assure regulatory requirements are being met for products
- Represents Merial position and interests in external trade organizations or professional societies
- Provide regulatory CMC expertise during due diligence
Due to tracking regulations, only resumes submitted directly via OneMERIAL for internal employees, and Merial.com/Careers for external applicants, can be considered.
Equal Opportunity Employer M/F/D/V Qualifications - Bachelors/Pharmacist or equivalent Degree with minimum of four years technical experience in the pharmaceutical industry either in manufacturing, product development or Quality Assurance.
- Effective written and verbal communication skills.
- Effective interpersonal and collaboration skills with the ability to work in a team-based setting; flexibility; and ability to proactively resolve problems.
- Ability to analyze, understand and interpret regulations and guidelines on product information.
- Effective negotiation skills.
- High level of attention to detail required.
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