Job details
Job type fresher
Full job description
Executive-regulatory affairs
About bluefish pharmaceuticals
Founded in sweden, with its long tradition of industrial entrepreneurship, bluefish pharmaceuticals has become
One of the most progressive generics pharmaceuticals companiesAt bluefish, we strive to make quality medicine
Accessible to more people.
Bluefish creates value in the full pharmaceutical value chain from developing to manufacturing and successfully
Marketing generic pharmaceuticals and we take pride in doing this in an innovative, responsible and cost-efficient
WayBluefish currently conducts operations in 19 countries in europe and, over the next few years, will also expand
Outside europe with the aim of becoming a global player.
Our corporate culture and close collaboration with development and manufacturing partners are integral parts of
Our effort to deliver quality products at affordable prices.
We offer a product portfolio consisting of a broad range of high-quality generics for all major therapeutic areasIt
Is part of our long-term strategy to expand the product portfolio of off-patent blockbusters while at the same time
Offering a broader range of niche products within more narrow disease areas.
Bluefish products all originate from a generic substance, where the efficacy and safety are well documented.
Through our many collaborating partners, we have access to a vast range of technology platforms, enabling us to
Develop and enhance the intellectual property of our product portfolio.
Our strategy of developing products based on well-known substances with an improved value to patients results
In a product portfolio with a significant market potentialWe achieve this with a relatively short development time,
Low risk, and limited investment.
By focusing on innovation and simplicity in both thought and action, and by taking responsibility on all markets and
Cost efficiency in all stages, we are creating a strong and vibrant brand that offers quality pharmaceuticals at prices
Affordable to all.
Bluefish provides quality generic pharmaceuticals at affordable pricesIts product portfolio contains a wide range
Of products within all major therapeutic areas.
Since its inception, bluefish has developed the platform and know-how to participate in and to be an integral part
Of all major steps of the value chain in the offering of generic pharmaceuticalsWith the vision of offering quality
Pharmaceuticals at prices affordable to all, we have to be innovative and at the same time cost-efficient in all
StagesThis includes operational excellence in departments such as product development, quality assurance,
Pharmacovigilance, ip and supply chain as well as marketing and sales.
Profile description
Bluefish is looking for profiles to fill the position of executive-regulatory affairs, contributing to the accomplishment
Of the regulatory affairs function objectivesThe position will report to head-regulatory affairsThe role would be
Involved in the below mentioned areas:
Submission of maa applications till end of procedure
Responsibility for planning and compilation/submission/follow up of marketing authorisation
Applications, variations, renewals and other relevant maintenance activities for dedicated products
Within eu.
Personally accountable for dedicated products to achieve product lifecycle and maintaining licenses.
Building and maintaining an optimal dialogue and relationship with health agencies.
Keep up to date knowledge in national and european union legislation and regulations.
Plan and coordinate maa (mrp, dcp, national) and ma transfers
Marketing authorization applications
• follow ups for dossiers from providers and additional requirements required for filings.
Checking of dossiers for any feasibility after receiving the dossier from provider.
Preparation of module 1 and rearrangement of dossier in module wise as per ich-ectd format and
Checking for accuracy as applicable for export markets.
Overall calculation for regulatory fees to be paid.
Comments from health authorities and response package
• evaluate and communicate the dossier comments and questions with the dossier provider and internal
Functions and set a timeline for the response documents.
Evaluate, compile and submit the response documents within the stipulated timeline.
Variations & renewals
• preparation, review and compilation of variation and renewal package.
Calculation for variation and renewal fees to be paid.
Ensure completed relevant checklists
Ensure tracking tools are updated
Administrative activitie
Keeping databases up to date at all times.
Candidate specifications
Education and experience
Minimum of a life sciences or pharmacy graduate fresher or up to 3 years of relevant experience in
Pharma industry bulk of which is in regulatory affairs
Excellent computer skills, including word and excel in a microsoft windows environment
Excellent interpersonal skills
Experience in european and global new submissions and post marketing maintenance activities
Skills & abilities requirements
Good team-worker
Collaborative cross functional working
Good, clear and transparent communicator (both written and oral) with acceptable command over
English
Assertive
Positive and “can do” attitude
Must have good problem-solving skills- striving for win-win solutions
Safety of the workforce
Personal development through self-learning
Email: hr@bluefishpharma.com
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Job activity
Posted 30+ days ago