Vacancies in Regulatory Affairs at Kinapse-Banglore: CMC Specialist, Publisher, Generalist & Director

Multiple Job vacancies in Regulatory Affairs at Kinapse-Banglore, India, UK and US Locations:

 

 

Regulatory CMC Specialist:

Location: Bangalore, India

Responsibilities

For non-complex and complex submissions, independently fulfil the following responsibilities (but not limited to):

Capable of identifying when to ensure line support required to provide additional guidance and direction
Undertake information processing activities with extremely high reliability with high quality and in tight timelines according to standard processes and operating procedures
Act as a subject matter expert and help the team members with day-to-day trouble shooting activities
Undertake or Assist in training and mentoring of team members depending upon project requirement
Involvement in work allocation, compiling and reporting the project completion reports on timely basis
Create error free high quality documents and other outputs according to tightly defined specifications
Participate in meetings with Client on a regular basis to understand the client’s requirement for a particular project and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints
Perform the self- and peer-review of submission packages using the checklist
Liaise with clients, or third parties in order to obtain documentation or relevant information required to execute work
Depending upon level of experience and responsibility; may take on supervision, mentoring and/or coaching of more junior members.

Candidate Profile

Educational qualifications: A minimum of a Post graduate degree from a well-known institution
Candidates will have any one of the following qualifications from a reputed university:
– Masters in Pharmacy
– Ph. D/ Post Graduate degree in Life Sciences
Significant knowledge on regulatory requirements and/or guidelines, post approval CMC documentation and exposure to various document management and publishing softwares are preferred

Key skill requirement

Sound knowledge of ICH guidelines and submission requirements of various markets such as USFDA, EMA etc.
Have significant knowledge of Quality related guidelines and regulatory requirements
Good understanding of manufacturing and all aspects related to product development
Ability to motivate team members, provide troubleshooting, tracking deadlines and acting as a second or third degree reviewer
Excellent written communication skills
Working knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel
An understanding of key aspects of CMC work i.e. Drug substance and product understanding, Analytical capabilities, familiarity and comfort with manufacturing and formulation development concepts and a sound understanding of stability.

Core competencies for this role include

Professional service mentality – willing to go beyond the call of duty to satisfy their clients
Commitment to highest quality outputs, including obsessive attention to detail
Enthusiasm and pro-activity
Team collaborators, ability to be successful working in team
Is this you? We would like to hear from you.

To apply, please email your CV to recruitment@kinapse.com

 

 

Regulatory Affairs Publisher

Location: Bangalore, India

Description

As a Publisher for the Kinapse Global Operations Team to Clients, the Publisher will work closely with the Global Operations Team Leader, Senior Publisher, Strategic Authors and CMC support operators to ensure delivery of the contractual Client product portfolio above and beyond Client’s expectations for quality, efficiency and productivity.

Global Operations Functional Team Performance

Support the publication of high quality regulatory submissions to health and regulatory authorities worldwide
Ability to manage workload capacity with ever changing deadlines/requirements with ability to assist & support other members of the team where required
Actively participate in development, review and process improvement activities.
Participation in Kinapse Publishing Team

Publish quality submission outputs in accordance with agreed processes, timelines, formats and standards
Liaise with senior publishing colleagues and strategic author team members, both locally & globally, to ascertain individual submission requirements for specific countries & their regulatory bodies
Maintain regular communication channel to keep teams apprised of the status of submission publication activities
Gain clear understanding of submission ready requirements and develop a good working knowledge of all tools/systems used in support of publishing processes
Management of individual workload.
Continuous improvement

Participate in knowledge sharing across Kinapse Operations Team members
Input into all Kinapse and Client publishing services quality and tracking systems
Demonstrate constant attention to detail to ensure each submission package is correct and in the required format and delivered in a timely manner to expedite publication.
Quality management

Actively participate in performance management initiatives such as periodic performance reviews/appraisals and where necessary assist with the training of new colleagues. Work closely with the Operations Team Leader/Senior Publisher to identify support and guidance training/coaching requirements. Offer support & guidance to other team members where possible once training is complete
Ensure all individual contributions to team deliverables have been quality checked in line with Client expectations before peer hand-off.
Experience and Competencies

2 to 5 years of experience in publishing of eCTD, NeeS and Paper submissions using various publishing tools
Life sciences degree desirable but not essential
Experience of working in operational publishing teams
Experience in Documentum-based dossier repositories.
Expertise required

Compliance checking, linking, Bookmarking, QC/ review of documents, Rendering Multiple Documents to PDF, Creation of external links, 5 in eCTD format.
Compilation of NeeS, Compilation of paper submission, QC/ review of dossier, Publishing & Validation
Good working knowledge of less complex tools/systems used in support of publishing processes, in particular eCTDXpress, ISIPublisher, ISIToolbox, Compose etc.
Good communication skills (both written and verbal)
Ability to prioritise and multi-task a number of projects
Integrity, credibility, and commitment to building the success of the Kinapse-Client partnership
Good understanding of existing regulatory agency standards and formats for submission and ensure that the CMC publishing output meets these requirements
Good knowledge of ICH/ regional eCTD guidelines
To apply, please email your CV to recruitment@kinapse.com

 

Regulatory Affairs Generalist

Location: Bangalore, India

Responsibilities

For complex submissions, conduct project start-up/kick off meetings and document review meetings with the project team to confirm submission strategy and approach
Collaborate with internal and external project team members for the generation, review and finalization of regulatory documents
Author and collate module 1 sections
Review the document content for appropriateness and revise the document to incorporate team comments/suggestions
Perform the self- and peer-review of submission packages using the checklist
Lead the project planning process for the regulatory maintenance of a portfolio of products
Ensure accuracy and completeness of all regulatory maintenance activities in scope in line with Sponsor’s expectations
Keep abreast of legislation and regulatory requirements for global submissions in scope
Responsible for regulatory intelligence gathering for a region/country, evaluation of this regulatory intelligence, proposal of impact to the Sponsor for endorsement and communication of impact to all impacted team members.

Candidate Profile

Educational qualifications:

A minimum of a Post graduate degree from a well-known institution
Candidates will have any one of the following qualifications from a reputed university:- Masters in Pharmacy- Ph. D/ Post Graduate degree in Life Sciences
Significant knowledge on regulatory requirements and/or guidelines, post approval RA documentation and exposure to various document management and publishing softwares are preferred
Key skill requirement

Sound knowledge of ICH guidelines and submission requirements of various markets such as EU, and rest of the world
Excellent written and verbal communication skills
Core competencies for this role include:

Effective management of individual and potentially team workload
Analytical capabilities, familiarity and comfort with regulatory concepts
Professional service mentality – willing to go beyond the call of duty to satisfy their clients
Commitment to high quality outputs, including obsessive attention to detail
Enthusiasm and pro-activity; Team collaborators, ability to be successful working in teams; Attention to detail
Multitasking, adaptability and flexibility planning
Good negotiation skills with internal stakeholders
To apply, please email your CV to recruitment@kinapse.com

 

 

Regulatory Affairs Director

Location: UK/US/India

Delivery and quality assurance of programs and technical excellence

Perform quality assurance of technical area in programs across the service line ensuring client satisfaction and quality of work.
Design and deliver training and development activities to build internal skills and capabilities within the service line

Business Development

Generate demand for Kinapse regulatory services with existing and new clients in conjunction with the Head of the Regulatory Service Line and Executive Sponsors of Client Account Groups (CAGs) leads
Own successful completion of relevant responses to RFIs/RFPs in collaboration with the Head of the Regulatory Service Line and the Executive Sponsor of Client Account Group
Co-ordinate Advise – Build – Operate BD activities for the service line and support the Head of the Regulatory Service Line and Executive Sponsor of Client Account Group led BD activities
Leverage partnerships for business development and complementary service delivery within the service line
Drive the development and publication of thought capital relevant to the service line

Strategy Development

Via knowledge and understanding in their area of expertise, propose and drive business strategy development and execution in conjunction with the Head of the Regulatory Service Line.
Propose and build potential partnerships with other companies to support the execution of the agreed business strategy of the service line.

Management of financial performance

Be accountable for meeting business performance targets assigned (wins; program delivery etc.)

Competencies and Experience required

Evidence of an extensive network in support of BD activities
Track record of business development success
Strong and principled leadership: models exemplary conduct and performance
Ability to directly oversee and lead programs
Active, continuous demonstration of the Kinapse values
Extensive experience and technical skills within Regulatory: along with SL Head, is a recognised “thought leader” internally, and probably externally
“Organisation-wide” thinking and approach
Influential individual with excellent client relationship management and communication skills
Integrity, credibility, and commitment to building the Kinapse brand in the marketplace
To apply, please email your CV to recruitment@kinapse.com

 

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April 8, 2015

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