GM - Global Regulatory Strategist

Job Title:

GM - Global Regulatory Strategist

Business Unit:

GDO

Job Grade

G7

Location :

Gurgaon/ Mumbai

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Job Summary

• To empower in providing leadership for the regulatory strategy of one or more in-line and pipeline assets across one or more therapeutic areas


• To collaborate with leaders across the organization to serve as the ‘face of the asset’ from a regulatory perspective


• To formulate, develop, and execute a comprehensive regulatory strategy integrating US and ex-US regulatory requirements


• To ensure the conceptualization, development, and implementation of efficient global registration pathways to secure approvals, as well as maintain and potentially expand licenses in one or more geographies


• To engage health authorities and drive product development, global registration, and ultimately achieve the desired labeling for one or more assets within or across therapeutic areas


• To develop a team of US and/or global regulatory leaders, as assigned


• To serve as a key member of the Global Regulatory Affairs Leadership Team (GRA LT), if assigned

Area Of Responsibility

• Provide strategic, tactical, and operational direction and guidance to product teams for assigned inline and/or pipeline assets in one or more therapeutic areas


• Serve as key corporate regulatory contact and source of regulatory information and guidance for the US and other applicable markets


• Serve as a line manager by constructing and developing a team (as resources are assigned)


• Responsible for developing, executing, and maintaining the regulatory requirements for assigned programs, as well as managing regulatory commitments


• Stay abreast of regulatory agency regulations, directives, guidelines, and policies that could impact product development, in order to assess approval pathways and identify potential issues


• Identify and communicate all product development issues to management that could impact product submission, approval, or launch


• Set and monitor submission timelines in coordination with other key stakeholders


• Facilitate and lead all communications with Regulatory Agencies or Health Authorities, as applicable


• Ensure communication with the regulatory body follows the established procedure within the department


• At times, other functional areas may need to discuss matters with the Health Authority alongside their counterparts at the regulatory agency. The Regulatory Strategist/Lead should always serve as the point of contact and lead this interaction


• Ensure that any communication documented according to established procedures is distributed within the Global Regulatory Affairs team and to any other external department directly affected by the communication


• Must be involved in writing or facilitating the authoring of certain regulatory sections of product submissions.


• Develops and manages relationships with external regulatory agencies, industry groups, and business partners.


• As applicable, shall review audit reports, regulatory agency inspection reports, and responses to inspection observations, if any, when received.


• Compiles, prepares, and reviews regulatory submissions to regulatory agencies, as applicable.


• Conduct department-level training, as necessary, to educate regulatory strategists and other roles within the department on regulatory requirements, policies, and procedures.


• Participate in the authoring and/or review of departmental procedures/guidance, as applicable.


• Participate in in-licensing/due diligence review activities, as needed

Qualification, Skill and Competencies Requirements

• Advanced degree preferred (PhD, MD, PharmD, MBA)


• Extensive global regulatory leadership as demonstrated by experience (> 15 years), milestones reached (e.g., original/supplemental approvals, expedited program designations), and health authority engagements (e.g., FDA, EMA, and others)


• Strong staff and organizational development experience (e.g., building teams, and coaching and training both new and experienced staff); demonstrated strengths in delegation, resource allocation, and workload prioritization.


• Broad experience in and across regulatory disciplines (notably global/regional strategy, labeling, clinical, nonclinical, CMC)


• Direct experience and expertise in authoring and filing regulatory documentation across major regulated markets


• Ability and interest in building and/or working a nimble resourcing environment

Travel Estimate

Job Requirements

Educational Qualification

 PhD, MD, PharmD, MBA

Experience

Tenure:  15+years

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).