Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide. Baxter had 2012 sales of $14.2 billion and has approximately 50,800 employees.
Post: Senior Manager, Reg Affairs-150005UK
Job Description
· Lead country team to for new product registrations, plant registrations, license extensions, variations, renewals according to agreed timeline, and ensure approvals in a timely manner
· Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
· Respond to DCGI’s requirements which satisfies dossier by strict deadlines.
· Maintain and archive regulatory files in a format consistent with requirements.
· Establish appropriate communication within RA and other functions primarily at project level. Develop regulatory project plans, and align with global, regional and local marketing strategies.
· Support regulatory activities relating to specific portfolio of products/projects (product owner)
· Prepare, review, and approve labelling and SOP’s
· Review promotional material or SOP’s for compliance with local regulations
· Maintenance of databases
· Respond to requests for information from global/regional RA colleagues
· Assist with the development of regulatory project plans and strategies
· Keep up to date with changes to regulations and standards, and ensure relevant colleagues are advised of the implications of such changes
· Liaison with Franchise and CMC Regulatory Affairs and other colleagues to ensure open and up to date communication of the status of products and projects and relevant regulatory requirements
Essential Skills
· Sound basis of Regulatory and scientific knowledge
· Attention to detail and Commitment to task
· Ability to manage complex projects and timelines in a matrix team environment
· Written and Verbal communication and presentation skills
· Ability to independently identify compliance risks and escalate when necessary
· Thorough knowledge of applicable procedures, specifications, regulations and standards.
· Organised – in self, work and environment
· Able to work in a matrix and cross-cultural environment
· PC skills including Word, Excel, and interest and ability to learn other programs as required
Education / Experience
· Advanced degree or equivalent in related scientific discipline with experience 10-12 years. experience in RA, with prior people management experience
· Bachelor/Masters/Doctorate degree or country equivalent in pharmacy or related discipline
· Good working relationship at the CDSCO/DCGI office
· Experienced on registrations of both Drugs and Devices
Additional Information:
Qualification: M.Pharm/B.Pharm
Location: Haryana-Gurgaon
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: DRA
Job ID: 212967
End Date: 20th July, 2015
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