Head Regulatory Affairs- 15+ Years- Mumbai

Location: Mumbai
Discipline: Healthcare/Life Science Research, Research
Job type: Permanent
Contact name: Crescendo Global

Contact email: india@crescendogroup.in
Job ref: 38510
Published: about 1 year ago

 

 

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.

 

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

WHAT IS IN IT FOR YOU?

An opportunity to work with global clientele in a fast-paced environment with a growth oriented & enthusiastic team. 

 

Reach us 

If you think that this role will add value to your career, kindly write me an email along with your updated CV on india@crescendogroup.in

 

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