Manager- Regulatory Affairs
Lonza Specialty Ingredients (LSI) combines technological innovation with world class manufacturing and process excellence. Together, these enable our customers to deliver their discoveries in key areas:
Microbial Control Solutions serves consumer and technical markets by safeguarding resources and peoples’ wellbeing. We are a trusted and innovative supplier of microbial control solutions and chemical technologies used in a wide range of industrial and consumer solutions. Our vast product portfolio of microbial control and chemical technologies offer quality products backed by technical and regulatory expertise, meeting our customers’ current and future needs.
Specialty Chemical Services provides solutions for composite materials and processing additives for technically demanding industries, such as electronics, transportation and aerospace. We also provide performance intermediates & chemicals for many industrial applications, such as Agro intermediates, food & feed ingredients, cosmetics, non-current good manufacturing practices (non-cGMP) intermediates, and custom development & manufacturing.
Job summary :
Responsible for providing the regulatory support, guidance and compliance for the LSI Business Units, covering the entire gamut of active ingredient and product regulatory activities crucial for India business.
Play a pivotal role in understanding the complex Indian and local regional regulatory environment and being a key resource for supporting and driving key business specific deliverables.
Liaison with industry leaders, policy makers and consultants to advocate Arch India regulatory and business needs.
To participate in industry forums and propagate Arch India and its products highlighting the regulatory compliance
Roles & Responsibility
Understand the registration process and requirement for conducting business in India and the local region eg. FDA, CIB, FSSAI, DCGI, Sri-Lanka etc. Keep updated changes of relevant new / draft legislation / regulation / guidance in the regulatory affairs arena and provide strategic regulatory inputs to all the LSI Business Units.
Supporting local manufacturing to gain all necessary product and substance regulatory compliance
Coordination and preparation of responses to questions raised by regulatory authorities during registration process and getting approval.
Follow up of post approval commitments, maintaining dossiers after initial approval by submitting relevant updates/changes as per appropriate, renewal of permits and licenses wherever appropriate.
Support the preparation of SDS, storage , labeling and packaging requirements to meet regulatory compliance for products manufactured and used in India
To respond to alleged violation of rules, regulations, policies, procedures and standard of conducts.
Challenge authorities when non-compliance issues are brought in for discussion
Coordinate with global team in dossier preparation and with third party regulatory consultants for dossier submission and to obtain regulatory clearances.
Collation of information and preparation of dossiers in a timely manner to get the registration procedures completed.
Representing Arch India and be the crucial link between Arch India and the relevant regulatory authorities and industry bodies to obtain requisite clearances, permits, licenses and permissions
Support Arch India’s customers on regulatory aspects pertaining to usage of our products
To conduct regulatory audits on Arch’s tollers to ensure strict regulatory compliance and support tollers (as required) with regulatory support
Perform other duties as assigned.
Education : Bachelor/ Masters in Life Science / Chemistry technical background
Additionally Business Management advantageous
Work Experience :
Requires minimum 8- 10 years of relevant experience in the field of regulations across Chemicals Industry
Ability to liaise with Govt. authorities and get things done
Knowledge of the Indian regulatory framework relevant to chemical industry.
A major part of the heritage of LSI is being able to deliver unique solutions to its customers. Being the driving force behind this approach – listening, asking, understanding to match the right elements in a new way has been an inherent part of our day-to-day business. Always with the goal to enable a competitive advantage for each customer with a specific product, package or solution. What makes YOU different?
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.