To coordinate regulatory activities throughout the regulatory life cycle by
carrying out project specific tasks related to writing and collecting
submission documents from cross functional departments to ensure an efficient
preparation of submissions that comply with latest regulations and within the
defined timelines.
Description:
Follows all relevant departmental policies, processes, standard operating
procedures and instructions so that work is carried out in a controlled and
consistent manner.
Follows the day-to-day operations related to own job to ensure continuity of
work.
Writes submission documentations including relevant correspondences with
health authorities to fulfil submission requirements in an efficient manner
that complies with standards and regulations. Coordinates all regulatory
activities for submissions throughout the regulatory life cycle from
preparation, submission, deficiency letters to approvals and variations to
ensure efficiency in execution for each step. Maintains awareness of
applicable regulations and guidance to keep up to date with the relevant
guidelines and information that could impact the regulatory projects.
Coordinates and follows-up with cross functional departments to ensure that
submission documents are available in time to meet submission timelines and to
ensure that documents meet the authority guidelines and standards. Assists
in data collection to contribute in the preparation of regulatory affairs
department reports. Communicates with third parties and licensors to ensure
that submission documents are available in time to meet submission timelines
and to ensure that documents meet the authority guidelines and standards.
Contributes to the identification of opportunities for continuous improvement
of processes and practices taking into account 'international best practice',
improvement of business processes, cost reduction and productivity
improvement.
Assists in the preparation of timely and accurate reports of regulatory
affairs to meet company and department requirements, policies and standards.
Complies with all relevant safety, quality and environmental management
policies, procedures and controls to ensure a healthy and safe work
environment.
Performs other related duties or assignments as directed.
Minimum Qualifications: Bachelor 's degree Pharmacy or PharmD.
Minimum Experience: 1 to 3 years ' experience in biopharmaceutical
industry.
Develops and ensures implementation of regional RA strategy for sanofi-aventis products. Serves as focal point between Affiliate RA and other RA functions. Responsibility of various countries or various registered products. Ensures the maintenance of the A.M.M.: renewals, variations, answers …
769 million lives touched by our products. Imagine what you could do at Novartis. No matter where you work, you could contribute to solving some of the toughest healthcare challenges and have an extraordinary impact on people's lives. Join us! We are looking for a Regulatory Affairs Associate …
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