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

Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information here.

Applicant Profile

Along with our brand-new career site, we've also revamped our application process. If you've applied for a position before April 16th 2025, you can log into your old profile to see the status of past applications. For the application you've will completed, and any in the future, you can create a new profile to check in on your status.

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 personalized support to help you navigate and use your benefits.

Voluntary Benefits

Our voluntary benefits provide additional protection from the high costs of healthcare not covered by health insurance.

We also have discount programs that offer exclusive savings on everything from auto, home, and pet insurance to low-interest personal loans.

Work/Life Support

We have several programs to support your work/life balance, including generous paid time off, back-up day care services, education assistance, and more.

OUR RECRUITING PROCESS

Depending on the position (level, functional area, country) the process can vary slightly.

You apply

Complete your online application for your preferred role(s) that match your interests and qualification. If you cannot find a suitable role please join our Talent Zone and stay connected for your next career opportunity.

We screen

We review your application and if we determine that you are a good fit we will move you to the selection process.

We assess

You are interviewed by phone, via video and/or face to face.

Mutual agreement

Ideally you are the perfect match for us We hope you consider us as your new employer.

Work your magic

To guarantee you a smooth start our onboarding preparation begins.

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