Senior Manager | Regulatory Affairs

What we Offer:

Continuous mentorship – you will collaborate with passionate peers and receive both formal training as well as day-to-day mentoring from your manager dynamic and supportive work environment– employees are at the centre, we value every individual and support initiatives, promoting agility and work/life balance.

Regulatory Strategy:
• Develop registration strategies and lead the registration process for all OTC/non-OTC products in India (locally manufactured and/or imported), including Rx and OTC allopathic medicine, Ayurvedic medicines, cosmetics, FSSAI products.

Management of Regulatory operations i n the assigned territories:
• Management of assigned regulatory projects (base and development projects).
• Devise and drive regulatory strategies to enable base business growth and deliver new innovation project s .
• Ensure regul atory compliance of registered products, promotional material and related commercial initiatives .
• Close collaboration with regulator y , medical, legal and quality functional groups.
• Provide lifecycle maintenance support for products from this site.
• Monitor, collect and interpret regulatory issues, legislations, trends and other regulatory intelligence or i nsights that w i ll i mpact P&G bus i ness, and communicate regu l atory risk assessment to the appropriate local and global P&G functions.

Exports
• Regulatory due diligence and support (strategy, filings, HA meetings and Approvals from Indian authorities or concerned state FDA) for products manufactured at Ahmedabad plant or other P&G manufacturing locations in India for its registration in for export countries.

External Affai rs:
• Interface with Gujarat FDA, and other pharma relevant authorities in Gujarat for plan for plant and product registrations and licences maintenance
• Interface with other relevant government agencies including ministry of Ayush, industry associations and key opinion leaders to assess the i mpact and i mplementation of requ i red compliance initiatives to meet all regulations, laws and industry policies that affect the i ngredients, packaging, marketing, advertising, labelling and production of our products.
• Interface and represent company interests with relevant government agencies, industry associations and/or other organizations for the purpose of negotiating legislation, regulations and/or guidelines that do not i mpose excessive or unfair burdens on our industry or products.

Collaboration with MFTs / Regulatory Leadership
• Day to day collaboration with Multifunction teams, LTs for projects and deliverables

Advice I Training/Compliance/other scope of work:
• Variation and Renewal of all licenses on time
• Change Control Management, Artwork Review, Specifications, Dossier readiness
• Provide training / coaching to RA teams on functional matters
• Provide advice and training on regulatory compliance to the local business .
• Ensure compliance requirements are met.
• Ensure full compliance of all marketed products and marketing/sales activities with national regulatory requirements including but not limited to advertising, packaging and communications, and import/export procedures.
• Management of Regulatory and compliance activities for assigned export markets (Sri Lanka, Nepal, and other assigned territories) .

Qualifications
• Bachelors / Masters degree in Pharmacy / medicines/allied streams
• Strong connect and experience of working with Gujarat FDA and its Ayurvedic department
• Sound Regulatory knowledge and understanding on India and Asian markets for Rx/ OTC/Ayurvedic medicines/FSSAI regulated Health supplements and Nutraceuticals /Medical devices/Cosmetics/Advertisement regulations/E.com
• Preferably, a 2-4 years of people management experience

Just so you know:

We are an equal opportunity employer and value diversity at our company. Our mission of diversity and inclusion is: “Everyone valued. Everyone included. Everyone performing at their peak”