Regulatory Affairs Manager
3 weeks ago
About Us
Rubicon Research Limited is a fast-growing pharmaceutical formulations company delivering value to our customers and investors by 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 that markets non-branded prescription products and Validus Pharmaceuticals that markets branded prescription products and promotes them to healthcare practitioners in the US.
We have two US FDA inspected R&D facilities – one each in India and Canada, and two manufacturing facilities in Maharashtra, India with multiple accreditations from multiple regulatory agencies such as US FDA, Food and Drugs Administration, Maharashtra (WHO-GMP accreditation) and Health Canada. Our facilities are equipped with a range of drug development and manufacturing capabilities across dosage forms.
Headquartered in Thane, India we have a sales and marketing office in New Jersey, USA.
Job Title: Regulatory Affairs Manager
Type: Full-time
Location: Thane, Maharashtra
Job Overview:
The successful candidate will manage product registrations in key regulated markets of Canada and Australia, including preparing dossiers, submitting applications for product registrations, addressing query responses to obtain product approvals, and meeting any annual requirements. They will also liaise with cross-functional teams and manufacturing plants to obtain necessary documents for product filings, interact with regulatory bodies on administrative and technical matters, and manage a team of professionals to deliver planned filings and approvals.
Key Responsibilities:
- Managing product registrations in key regulated markets of Canada and Australia, including dossier preparation, submission, query response, and registration.
- Submitting post-approval variations and meeting annual requirements in these markets.
- Liaising with cross-functional teams and manufacturing plants to obtain necessary documents for product filings.
- Interacting with regulatory bodies on administrative and technical matters.
- Managing a team of professionals to deliver planned filings and approvals.
Requirements:
- Minimum 10-15 years of experience in regulatory affairs, preferably in CA and AU markets.
- Proven experience in dossier preparation, submission, query response, and registration in key regulated countries.
- M.Pharm or M.Sc degree required.
- Excellent communication and planning skills.
Salary Estimate:
$120,000 - $180,000 per annum, depending on experience and qualifications.
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