Pharma Regulatory Affairs Specialist at Medtronic
Medtronic is a global leader in medical technology, services, and solutions. With operations in more than 160 countries, we provide innovative healthcare products and therapies to improve the lives of millions of people worldwide. Our mission is to ensure compliance and quality in everything we do, with a strong focus on ethics and integrity.
Job Title: Regulatory Affairs Specialist-II
Location: Gurgaon, Haryana, India
Job ID: 23000JFW
A Day in the Life:
- Manage, plan and execute the preparation, review and submission of dossiers for product registrations, import licenses and other approvals from regulatory agencies (registrations and renewals) thereby supporting the business units and supply chain management in compliance with regulatory requirements in India.
- Coordinate with global regulatory teams, local BU & other functions, for regulatory strategies and all documentation support required for regulatory submissions in India.
- Submit and track registration/re-registration applications with the authorities.
- Liaise with product divisions and obtain relevant details for filing changes to the approved products/licenses.
- Assess the Change controls from the product divisions through post approval change management and continuously ensure regulatory compliance (reporting of adverse events/field actions, etc.).
- Understanding & interpretation of law & the local regulatory requirement and implementing same in submission with compliance.
- Close monitoring of any changes in local & global regulations and communicating same within the department and respecting & following all SOP / system implemented within the department and organization.
- Ensure business continuity through regulatory filings, obtaining regulatory approvals and continuously ensuring regulatory compliance. Also ensure continuous implementation of the Quality Management System in India.
- Supporting the Marketing Teams on Tender related issues.
- Development, implementation and maintenance of regulatory systems pertaining to regulatory document management (SOP’s, archival, trackers and systems) within the department and organization.
- Interface and coordinate with regulatory agencies/competent authorities (CDSCO, CDDA, DGDA, State FDA, DoT, AERB, etc.) with respect to submissions, obtaining registrations/licenses, amendments, regulatory compliance, packaging, quality control testing or release, etc.
- Work with clinical team on submission and approval of clinical trials applications (clinical trial approvals, import licenses/test licenses for clinical trial, amendments, etc.) from various regulatory agencies in the India.
- B Pharm / M Pharm / Bachelor or Master Degree in Bio-Medical Engineering / Science discipline with training in Regulatory Affairs
- Must have at least 5-7 years’ experience in the pharma/medical device/life science industry with at least 2-3 years’ medical device experience in regulatory affairs
- Conversant with various regulatory requirements for India with respect to medical device registration, import, clinical trials, etc.
- Knowledge in application of CDSCO, FDA, CE and other regulatory requirements especially in the area of Quality Systems and Design Control as applied to projects from design inception to manufacturing release
Nice to Have:
- Excellent communication and interpersonal skills – Good verbal communicator and presenter
- Customer focused: Understands and delivers customer service
- Ability to quickly establish credibility with all levels of Regulatory Agencies, Government, etc.
- Good verbal and written communication skills in English – with colleagues, management and external authorities
- Self-motivated and positive “Can do” attitude. Can work autonomously but is also a team player
- Outgoing and friendly: Enthusiastic, energetic, diplomatic, willingness to learn
- Be able to plan, manage, organize and report in an efficient way
- Be independent, persuasive, innovative and able to summarize
- Good time management: Well organized, able to set and reset priorities
- External Focus:
- Interacts regularly with customers and seeks inputs.
- Well informed regarding market and industry/competitors operating in territory.
- Initiates or champions changes from the outside in.
- Explores new opportunities and asks informed questions.
- Experience of dealing with various functions internally and externally
- Consistently delivers results on time and exceeds expectations.
- Ensures the processes are capable of achieving the desired direction.
- Clarifies roles and aligns resources allowing for faster execution.
- Orchestrates resources for optimal use. Continually monitors progress and seeks continuous improvement.
- Inspires Others:
- Has the ability to connect, motivate, engage the sales force
- Builds networks to obtain cooperation without relying on authority.
- Makes active attempts to influence events to achieve goals.
- Establishing procedures to monitor the results of delegations, assignments, or projects;
- Seeks and values different perspectives and ideas to foster an inclusive work environment
- Clear Thinking:
- Understands strategic contexts, identifies opportunities.
- Is able to anticipate risks, evaluate options, and defines priorities for the team.
- Establishing a course for self and for others to accomplish a specific goal; planning proper assignments of personnel and appropriate allocation of resources.
- Committing to an action after developing alternative courses of action that are based on logical assumptions and factual information and that take into consideration the resources, constraints, and organizational values.
Editor’s Note: Pharma Regulatory Affairs Specialist at Medtronic. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.