Senior Manager

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 in 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 projects.
• Ensure regulatory compliance of registered products, promotional material and related commercial initiatives.
• Close collaboration with regulatory, 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 insights that will impact P&G business, and communicate regulatory 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 Affairs:
• 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 impact and implementation of required compliance initiatives to meet all regulations, laws and industry policies that affect the ingredients, 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 impose 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
• Preferably, a 2-4 years of people management experience