Regulatory Affairs Manager for Global Market Expansion
7 hours ago
About Rubicon Research
Rubicon Research Limited is a leading pharmaceutical formulations company that specializes in developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets.
We have an established marketing, sales, and distribution platform in the US through our subsidiaries AdvaGen Pharma and Validus Pharmaceuticals. Our product portfolio comprises over 250 SKUs across more than 70 product families.
Headquartered in Thane, India, we have a sales and marketing office in New Jersey, USA. With two FDA-inspected R&D facilities in India and Canada, and two manufacturing facilities in Maharashtra, India, we possess a range of drug development and manufacturing capabilities across dosage forms.
We are seeking an experienced Senior Manager, Regulatory Affairs to manage product registrations in key regulated markets of Canada and Australia. The successful candidate will be responsible for preparing dossiers, submitting applications for product registrations, addressing query responses to obtain product approvals, and meeting any annual requirements.
Key Responsibilities:
- Managing product registrations in key regulated markets of Canada and Australia, including preparing dossiers, submitting applications for product registrations, and addressing query responses to obtain product approvals.
- Submitting necessary post-approval variations and meeting any annual requirements in these markets.
- Liaising with cross-functional teams and manufacturing plants to obtain needful documents for product filings.
- Interacting with regulatory bodies as required on administrative and technical matters.
- Managing a team of professionals to deliver planned filings and necessary approvals.
Qualification:
- Must have 10-15 years of regulatory experience, especially in CA and AU markets.
- Should have experience in dossier preparation, submission, query responses, and registration in key regulated countries.
- Should be an M.Pharm/M.Sc holder.
- Good communication and planning skills.
Salary Information: We offer a competitive salary in the range of $120,000 - $180,000 per annum, depending on experience and qualifications.
Location: Thane, Maharashtra
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