Expert Regulatory Cmc

Job Id

291455
- Bangalore, Karnataka, India
- Job Type

Full-time

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimageable with us.

Your Role:

- Support and implement CMC Regulatory Intelligence activities (NB this is a non-product specific role):

- Databases (e.g., CMC Regulatory Country Requirements, Life Cycle Management/Investigational Medicinal Product Catalogues, Wiki-handbook) maintenance and their continuous improvement (including liaison with external data providers, as appropriate).
- Active participation in Change Control Process meetings, Chair of Quality Regulatory Assessment Committee (QRAC) meetings and monthly updates sessions, author/co-author of Position Papers and responses to Reg CMC queries, SME for guidelines revision, etc.).
- Ensure alignment between CMC Regulatory Intelligence and GRA CMC & Device teams (e.g., by improving interoperability, agility, engagement and cohesion).
- Deliver, from a non-product specific perspective, on small molecules, large molecules, medical devices (i.e., drug-device combinations) with regards to marketed post-approval activities as per CMC Regulatory Intelligence Road maps.
- Participation in Trade Association calls in listening & learning/observer mode by leveraging the discussion and lessons learnt onto CMC Regulatory Intelligence databases.
- Provide support on digitalization projects.
- Effective utilization of Veeva system for all the CMC regulatory activities.

Who You are:
Education
- Degree in a Life Science, Medical, PharmD or related discipline (minimum MSc or equivalent degree). Higher degree preferable (e.g. PhD in a scientific discipline) or education in Regulatory Affairs.
- 10 years of overall work experience (e.g. generated in Pharma environment, Competent authority, Academia, R&D, Consultancy) related and applicable to this CMC Regulatory Intelligence role. Minimum 5 years of Global CMC regulatory experience.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

and become a part of our diverse team
US Equal Employment Opportunities
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
- Notice on Fraudulent Job Offers
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Applicant Profile
WHAT WE OFFER
Money makes the world go round. But at our company there’s more than just financial rewards. We offer a range of attractive benefits to help you work your magic.
Saving & Finacial
Our 401(k) Plan includes a generous company-matching contribution and an additional discretionary contribution each year.
We also provide tax-advantaged accounts for you to save for healthcare, commuting expenses, company-provided and buy-up life insurance to help you protect your financial future.
Health & Wellness
We offer comprehensive medical, dental, & vision coverage-including virtual care through Telehealth & free behavioral health counseling sessions through our Employee Assistance Program.
We also offer a wellness incentive program and personaliz