Senior Regulatory Affairs Expert– 15+ years – Mumbai
An exciting job opportunity for Professional with Biotech/Pharmaceutical or CRO industry with exposure to global regulatory requirements.
YOUR FUTURE EMPLOYER: One of the major industry leaders in Information Technology Services & Consulting.
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
Create new offerings and enhance existing ones
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
Guidance to the team both SME and Project to expand scope of business
Review/enhance/develop competency plan to reach the next level
Guide teams for use of technology in regulatory such as platforms, automations, use of AI/ML etc.
Be a lead for all regulatory RFI/RFP/Analysts solutions • Implement cross pollination of Ideas
Establish connects with heads of regulatory in existing and new sponsors
Ideate transforming ideas for sponsors and its implementation
Proactively discuss with customers about point of view for new regulation impact, process improvements use of technology
Academic Qualification & Experience:
Masters/ Ph.D. in Pharmaceutical Science/ Life Sciences
With minimum 15 years of experience of which last 5 years as head of regulatorty
Strong working knowledge of global regulatory (FDA, EMA, ICH, etc.) guidelines
Strong experience in new registrations and life-cycle maintenance for Pharma, Consumer healthcare and medical devices
Strong experience in developing and communicating global CMC and regulatory strategy
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
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.
Ability to self-organize, coordinate, and prioritize multiple tasks with competing activities across several parallel tasks
Strong interpersonal, collaboration and communication skills
Attention to detail and ability to analyze data
Capability to distinguish areas of potential concern and communicate concerns effectively to stakeholder
WHAT IS IN IT FOR YOU?
An opportunity to work with global clientele in a fast-paced environment with a growth oriented & enthusiastic team.
If you think that this role will add value to your career, kindly write me an email along with your updated CV on email@example.com
Disclaimer: Crescendo Global is an ISO 9001:2015 certified Leadership Hiring consulting arm of Crescendo Group with expertise in mid to senior level niche recruitment. We are passionate about empowering job seekers and employers with an engaging memorable job search and leadership hiring experience. Crescendo Global does not discriminate on the basis of race, religion, color, origin, gender, sexual orientation, age, marital status, veteran status or disability status.
Note: We receive a lot of applications on daily basis so it becomes a bit difficult for us to get back to each candidate. Please assume that your profile has not been shortlisted in case you don’t hear back from us in 1 week. Your patience is highly appreciated.
Profile Keywords FDA, EMA, ICH, clinical research, preclinical research, biotech, pharmaceutical research, clinical trials, clinical quality, new molecular entities, CDM, PV, MW, RFI, RFG, Regulation, Regulatory Affair,Global Document Management System (GDMS