Senior Specialist - Regulatory CMC

Posted 22 Feb 2024

Bangalore, Karnataka - India

Req Id 270299

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.
 


Job Description:

Title: Senior Specialist

Location: Bangalore – Electronic City

 

Your Role:

  • Ability to contribute to the dossier content and to support the life cycle management of regulatory Devices and Drug/Device combination activities.
  • Ability to develop, prepare and implement successful regulatory strategies and dossiers.
  • Experience in preparation and management of regulatory documentation, including full global submission roll outs (new product application) or large variations for medical devices and/or drug device combination products.
  • Experience with life-cycle management activities within the medical devices and drug/device combination products including prefilled pens, electronic autoinjectors and pre-filled syringes in the EU/US and International markets.
  • Understanding and awareness of global pharmaceutical and medical device legislation
  • Awareness of regulatory affairs contribution to Pharma business
  • Basic understanding of concepts of project management and Regulatory affairs
  • Good written and spoken English communications.  
  • Ability to think strategically, to perform root cause analysis and to propose and drive continuous improvement.
  • Normal and routine office duties (hours of work may be adapted to match the Global team in EU and US region)
  • Position may require both domestic and international travel.

 

Who you are:

Education

  • Degree in a Life Science related disciplines, Pharmacy, preferably higher degree (e.g., MSc in scientific discipline or

M. Pharm or Masters in Regulatory affairs)

 

Work experience:

  • 7-10 years of overall work experience in Pharma environment
  • Competent authority or Academia/R&D experience related to the role.
  • Minimum 5 years of experience in regulatory affairs in medical devices and drug/device combinations.

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!

Apply now 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.

We are committed to an equitable hiring process for candidates from a diverse range of backgrounds. As part of this commitment, applicants with disabilities may be entitled to reasonable accommodations. Please contact USLeavesandAccommodations@milliporesigma.com, if a reasonable accommodation is needed or if you otherwise need assistance to participate in the hiring process.


North America Disclosure

If you are a resident of California, Colorado, New York, or Washington, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.


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