Senior Role - Regulatory Affairs - Radiation Industry

Regulatory Affairs

Description :

- The incumbent will manage the Regulatory Affairs function and have hands-on responsibility for the development and deployment of regulatory strategy as well as design, administration, and maintenance of regulatory operations including interface with AERB.

- Must be an experience RSO level 3 certified having experience in working in a radiation industry.

Responsibilities :

- Responsible for overseeing the company's regulatory strategies and policy development, and directing related resources to optimize efficiency and ensure expected outcomes.

- Provide guidance and advice on all regulatory affairs in support of goals involving Product Development and Commercialization, regarding regulatory time-lines, regulatory strategy, and operations.

- Oversee regulatory operations including planning, generation, and compilation of submission-related materials for applications, registrations and all other correspondence associated to execute regulatory operations activities associated with paper-based and electronic submissions.

- To Support the BU Regulatory Affairs function in achieving regulatory goals and objectives and proactively support the organisation in achieving the necessary regulatory submissions needed for targeted market areas.

- Generate and review submission materials for completeness and internal consistency with other documents; assure readiness for submission by identifying missing information, proposing corrections regarding internal consistency and regulatory issues, compiling relevant submission materials needed to meet applicable regulatory requirements.

- Act as a designee representing the company with health authorities and partners including someone having strong relationship with AERB.

- Developing and maintaining regulatory knowledge required in the country for organization's business need. Preparing, submitting and maintenance of product certificates from FDA, CE etc for products sold in the BU.

- Maintaining knowledge of the authority's approval system and developing working relationship with local experts in Business Unit, interact with PSC.

- Set up test requirements for testing outside the country, for imported products.

Authorities :

- Ability to effectively interface with internal customers, 3rd-party partners and regulatory authorities.

- Ability to work effectively in a team environment.

- The candidate will be a problem-solver with the ability to employ sound judgment to make difficult decisions under challenging circumstances.

- Implement strategies and policies, in the business unit, as appropriate to the quality system of the region.

- To approve processes in the Business Management System, (QMS) in India.

- Sign regulatory documentation in accordance with processes and instructions.

- To represent the business unit in Regulatory/Quality externally.

Relevant Knowledge, Skills And Competencies :

- University degree in relevant subject with minimum 10 +years of experience.

- The candidate shall possess proven experience in the planning and preparation of submissions for regulatory applications, amendments and other correspondence, with particular focus in preparation of Clinical and Non-Clinical portions of such submissions.

- The candidate will be a proven leader in the Regulatory Affairs functions combining excellent technical expertise with strong business acumen possessing at least ten (10) years of experience.

- Demonstrates Maturity and Counsel. Attributes confidentiality/Trustworthiness

- Confident, articulate and flexible, focused on achieving financial and personal goals.

- Excellent team player at all levels with strong interpersonal skills.

- Reasonable knowledge of organizations core products is preferable

- Strong interpersonal and multi cultural skills

- Persistent, enduring and prepared to make strong personal commitments

- Incorporates Values and quality systems.

- Ability to travel extensively if required.