Regulatory Affairs Manager- India

8 - 10 Years
Trivandrum

Job Description

JOB TITLE: Regulatory Affairs Manager, India


JOB SUMMARY
Performs regulatory activities and is responsible to manage and maintain product and site licences for the manufacturing site. Provides regulatory support related to the launch of new products, registration efforts for other geographical regions and regulatory systems compliance in the area of medical device and drugs.


ESSENTIAL DUTIES
Provides technical guidance and regulatory training/mentoring to other Regulatory Associates and/or cross functional teams
Develops, and is responsible to develop regulatory solutions to problems of moderate to intermediate complexity that may affect diverse function areas of the business.
Create new methods, techniques and/or processes across job areas or functions exerting some influence on the overall objectives and long-range goals
Manages functional groups product compliance, change management, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives
Responsible for overseeing regulatory compliance, development and timely national regulatory submissions, ensuring that all regulatory activities are conducted with the highest integrity and in an ethical manner
Reviews staff submissions to identify adequacy of sections, completeness and consistency of story and overall content of submissions, may be responsible for authoring submissions when needed
Interprets, executes, and recommends modifications to operating policies at business level. Will establish operating policies within specific business operating area and recommend policies that impact other areas.
Communicates regulatory strategy effectively to all departments, senior management, regulators, and regulatory agencies to achieve timelines
Ensures that all outside official communications comply with the appropriate regulations and internally approved regulatory and marketing claims
Reviews and prepares for Post-market regulatory actions to national authorities as and when required
Acts a leader who embodies regulatory expertise as well as business acumen with a positive corporate mindset


MINIMUM QUALIFICATION REQUIREMENTS
Education
Bachelors degree in physical/biological sciences or engineering preferred, or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered

Salary: Not Disclosed by Recruiter

Industry:Medical / Healthcare / Hospitals

Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category:Drug Regulatory Affairs/Documentation

Role:Documentation/Medical Writing

Employment Type:Permanent Job, Full Time

Keyskills

Desired Candidate Profile

Experience
Minimum 8 years experience in Regulatory Affairs and at least 2 years direct management experience preferred
Direct experience in approvals for devices or drugs or biologics in India
Possesses working knowledge of EU Medical Device Directive
Possesses strong knowledge of medical device standards including sterilization, biocompatibility, EMC standards etc.
Experience in working within a manufacturing and R&D environment will be an advantage
Experience in an environment where skills in negotiation, listening, persuasion, collaboration, compromise and analytic based judgement is used daily

Skills

Demonstrated success in the management of regulatory submissions in India
Knowledge of technical aspects of regulatory profession, combined with scientific understanding and project management skills
Understands how product approval strategies interact with business strategies. Identifies regulatory and clinical challenges and ability to resolve them through collaboration
Recognized as an emerging authority within the business or function with broad understanding of and experience working with multiple functions that are unrelated
Able to manage ambiguity and have ability to fill gaps with alternative data
Possess technical understanding of medical device design and manufacturing
Possess business insight and have ability to understand how product approval strategy interacts with business strategy, may involve in creating/ proposing such strategy
Nimble learning and able to actively seek out relevant legislation and competitive information on product lines
Must be results oriented and decisive. Failure to obtain results or arrive at approproiate decisions in a timely fashion could impact compliance risk or cause delays in planned product launch.
Demonstrated analytical and creative thinking skills and the ability to solve complex problems
Able to mentor and develop talent of direct reports
Ability to interact with diplomacy and tact while maintaining appropriate assertiveness
Willingness to take ownership and accept responsibility, ensuring accountability for actions and decisions
Must be detail oriented, well organized and able to work both independently and in teams
Knowledge and use of relevant PC software applications and skills to use them effectively
Demonstrated ability to communicate effectively both verbally and in writing

Certificates, Licenses, Registrations

Education-

UG:B.Sc - Any Specialization, Biology, Physics, B.Tech/B.E. - Any Specialization

Doctorate:Doctorate Not Required

Company Profile

Terumo Penpol Pvt Ltd

Terumo Penpol personifies the story of a home grown R&D initiative commercialized successfully. Practicing the concept of � Quality First � approach in manufacturing, Terumo Penpol has been serving Blood Centers across the globe for more than thirty years. Partnering with Terumo Corporation, Japan, a global leader in healthcare products, has enabled Terumo Penpol to harness the combined strengths in Technology and Manufacturing to continue redefining standards in Blood Transfusion.With Terumo’s recent acquisition of Terumo BCT, Terumo has become the world leader in Blood Management. The Blood Transfusion division of Terumo is being re-organized under the newly acquired company which has been renamed as Terumo BCT. The Apheresis and Cellular Therapy products of Terumo BCT complements Terumo Penpol products to provide a full range of blood collection, storage and processing solutions for Hospitals and Blood Centres in India and other countries
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Contact Company:Terumo Penpol Pvt Ltd