Job Title: Regulatory Affairs Labeling
No. of Posts: 2
Responsible for leading a team focusing on Labeling development and creation to support regulatory submissions and for commercialization. This is to be accomplished by planning and managing the activities of the group. Strong linkages need to be established within Global Regulatory Operations and with the Regulatory Market Affiliate, as well as with Quality and R&D.Responsible for leading a team focusing on Labeling development and creation to support regulatory submissions and for commercialization. This is to be accomplished by planning and managing the activities of the group. Strong linkages need to be established within Global Regulatory Operations and with the Regulatory Market Affiliate, as well as with Quality and R&D.
1. Responsible for the development and maintenance of an effective labelling process for the preparation, review and approval of draft and final labels that meet regulatory requirements for the purposes of obtaining product approval and for commercialisation.
2. Responsible for planning workload/projects for labeling (i.e. submissions, training plans, deficiency responses, etc.) to ensure submission and approval timelines are met, liasing with the Regulatory Affairs New Products team and Regulatory Affairs Marketed Products team.
3. Prioritizes projects in support of commercial business needs for New Product Launch, Global Supply Program Management and SMD-Consumer Products Private Label team.
4. Responsible for ensuring timely product approval with high quality technical submissions and monitoring Agency reviews with the Regulatory Market Affiliate.
5. Develops departmental standards and operating policies and procedures. Provides technical guidance in the review and evaluation of submissions to ensure overall quality and compliance of work.
6. Represents Regulatory Affairs and provides impact analysis in relevant forums associated with NPD product development and commercial product launches. Fully support the GPT team and assume responsibilities as allocated to ensure timely management of projects within the team.
7. Develops regulatory solutions and implements action plans for identified project issues to mitigate risks, informing and escalating as required.
8. Develops and maintains effective relationships with external vendors, suppliers, business partners and internal stakeholders in order to ensure business needs are met.
9. Implements business objectives, R&D initiatives and regulatory strategy focusing on process improvements.
10. Recruit, train, develop and manage effectively the ongoing performance of their direct reports, which includes, but is not limited to:o Ensuring their Job Descriptions are reviewed, signed and sent to Employee Services, annually, o Reviewing and updating employee development plans, ensuring that all employees are properly trained and qualified to execute their duties,o Providing coaching, feedback and recognition,11. Responsible to ensure compliance of team members (direct reports) with Safety and Employment policies (e.g., Respect in the Workplace Prevention of Violence and/or Harassment).
12. Stays abreast of changes in regulatory environment / trends.
13. Works as a member of a team to achieve all outcomes.14. Performs all work in support of our Corporate Values of Passion, Perseverance, Courage and Collaboration; Demonstrates strong and visible support of our values.15. Performs all work in accordance with all established regulatory and compliance and safety requirements.16. Perform other duties as assigned.
- Minimum MSc./M Pharma degree or equivalent in Chemistry or Pharmacy or Life Sciences.
- Minimum 8 years experience in the pharmaceutical industry with at least three years experience in senior
- Regulatory Affairs role.
- Minimum two years of experience in a management role within the pharmaceutical industry.
- Detailed knowledge of multiple regulatory requirements e.g., TPD, FDA, EU, TGA, etc.
- Excellent oral/written communication, leadership, organizational and interpersonal skills.
- Computer literate. Familiarity with IT systems, e.g. databases.
- Experience in leading a team of professionals.
- UG -B.Sc – Any Specialization, B.Pharma – Pharmacy
- PG – MS/M.Sc(Science) – Any Specialization, M.Pharma – Pharmacy