GRCY-0, Regulatory Affairs Head India

Posted 29 Jan 2024

Mumbai, Maharashtra - China

Req Id 271489

 

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 unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 


Purpose of the role:

Strategic direction and management of the Regulatory Affairs business unit to provide regulatory services and initiatives in support of India's business objectives while maintaining  Healthcare profile as a recognized ethical and responsible, research-based biopharmaceutical leader within its therapeutic areas in India. The role is a part of the leadership team for Healthcare in India and is the seniormost representative for regulatory matters driving internal, and external stakeholder management, advocacy and representing the company in industry forums.

 

Your role: 

1. People Management

  • Be actively involved in the recruitment, development and training of direct reports
  • Coach and counsel all direct reports in an appropriate and timely manner
  • Conduct and records regular half yearly and annual performance reviews as well as personal/career discussions with all direct reports in line with the company's Performance management Process
  • Ensure all direct reports work within both the company policies and Industry guidelines and apply the company values in their daily activities.
  • Drive the strategic direction of the Regulatory Affairs business unit to support business objectives in a timely, effective, ethical and professional manner.
  • Represent Healthcare INDIA local Regulatory business unit with relevant global functions and stake holders.
  • Coach and guide the local team on external and internal stakeholder management
  • Ensure all activities of company are consistent with current medical and scientific knowledge, industry and regulatory guidelines as well as corporate standards relevant to regulatory and quality activities and ethical behaviour.
  • Together with Global and the Managing Director - INDIA and in collaboration with the Business Units ensure that adequate resources, structure and processes are in place to ensure achievement of INDIA business objectives. 
  • Provide leadership, coaching and support for both direct and indirect reports especially for the regional Regulatory hub ensuring the respective teams/functions support Healthcare INDIA business objectives. 


2. Regulatory

  • Have a deep Understanding of the regulatory eco-system for healthcare business in India advising the country MD in regulatory topics
  • Build and represent Healthcare externally with key government and industry stakeholders
  • Responsibility for INDIA’s filing strategy to maximize business outcomes.
  • Lead pro-actively all regulatory file submissions, comply with the India’s regulations and internal process, train regional hub members appropriately.
  • Provide senior management and Country Leadership Team with assessment of impact of new and changing regulations in the India and Global regulatory environments on the local business including potential risks and mitigation strategies
  • Review and recommend policies, objectives and plans, to ensure that data related to a drug under development will fulfill the needs of regulatory authorities, and thereby assuring prompt approval and launch.
  • Develop required regulatory standards and standard operating procedures.
  • Ensure all licenses and regulatory compliance topics are properly monitored and up to date to enable smooth operations for HC in the country

     

3. General

  • Provide regulatory and quality expertise at cross functional project team meetings
  • Ability to build strong internal networks and position self as expert with cross functional peers
  • Support, lead, coach, motivate and performance manage the team for career development
  • Ensure that the Regulatory Affairs team is adequately supported in its professional development to the highest standards of professional conduct and expertise
  • Provide financial resources planning estimates for department in annual budgeting process
  • Contribute to Country Leadership Team and pro-actively lead Regulatory topics
  • Develop and implement the overall business plan for the business unit once approved
  • Apply new technologies and processes from within the Regulatory area, to the business unit
  • Conduct financial analysis and reporting relevant to the business unit and provide information to Global and the Managing Director
  • Report to the Regional/Global & Managing Director as required
  • Maintain regular communication between business units and other internal customers
  • Actively participate in the Commitment Process and Personal Development plan
  • Work within company Standard Operating Procedures, industry guidelines and apply Company Values and Code of Conduct in daily duties activities.


Who you are:

  • Strong knowledge of appropriate regional and global pharmaceutical regulations, requirements and standards.
  • Strong ability to drive and connecting with the Indian health authority officers at DCGI.
  • Minimum 10 years of experience in pharmaceutical industry in India.
  • Experience with managing complex international regulatory submissions.
  • At least 5 years leading and managing direct reports, with Strong team leadership and people development skills.
  • Excellent knowledge of process development and continuous process improvement.


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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