Head - Regulatory Affairs - Biotech/Pharmaceutical

An exciting job opportunity for Professional with Biotech/Pharmaceutical or CRO industry with exposure to global regulatory requirements.

LOCATION: Mumbai

YOUR FUTURE EMPLOYER: One of the major industry leaders in Information Technology Services & Consulting.

RESPONSIBILITIES -

1. Enhance and develop a complete regulatory dept for which work in tandem with other depts such as PV, CDM, etc for a cohesive clinical research/pharma/device strategy

2. Create new offerings and enhance existing ones

3. Thorough understanding of global regulatory requirements and use this understanding to develop regulatory affairs. Be abreast with latest regulation and the trends in the industry

4. Guidance to the team both SME and Project to expand scope of business

5. Review/enhance/develop competency plan to reach the next level

6. Guide teams for use of technology in regulatory such as platforms, automations, use of AI/ML etc.

7. Be a lead for all regulatory RFI/RFP/Analysts solutions - Implement cross pollination of Ideas

8. Establish connects with heads of regulatory in existing and new sponsors

9. Ideate transforming ideas for sponsors and its implementation

10. Proactively discuss with customers about point of view for new regulation impact, process improvements use of technology

Academic Qualification & Experience:

1. Masters/Ph.D. in Pharmaceutical Science/Life Sciences

2. With minimum 15 years of experience of which last 5 years as head of regulatorty

3. Strong working knowledge of global regulatory (FDA, EMA, ICH, etc.) guidelines

4. Strong experience in new registrations and life-cycle maintenance for Pharma, Consumer healthcare and medical devices

5. Strong experience in developing and communicating global CMC and regulatory strategy

6. Ability to work effectively with cross functional teams including product development, manufacturing, QA, supply chain and technology excellence to assure alignment of registration strategy for all new or modified formulations and high quality of developments

7. Strong computer skills with an expert command of Microsoft Office and ability to work with various tools and systems; viz. Global Document Management System (GDMS), TrackWise, Veeva Vault, etc.

8. Ability to self-organize, coordinate, and prioritize multiple tasks with competing activities across several parallel tasks

9. Strong interpersonal, collaboration and communication skills

10. Attention to detail and ability to analyze data

11. Capability to distinguish areas of potential concern and communicate concerns effectively to stakeholder